[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Proposed Rules]
[Pages 15173-15188]
[FR Doc No: 2016-06360]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 878, 880, and 895

[Docket No. FDA-2015-N-5017]
RIN 0910-AH02

Banned Devices; Proposal To Ban Powdered Surgeon's Gloves,
Powdered Patient Examination Gloves, and Absorbable Powder for
Lubricating a Surgeon's Glove

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that Powdered Surgeon's Gloves, Powdered Patient Examination
Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present
an unreasonable and substantial risk of illness or injury and that the
risk cannot be corrected or eliminated by labeling or a change in
labeling. Consequently, FDA is proposing these devices be banned.

DATES: Submit either electronic or written comments by June 20, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-N-5017 for ``Banned Devices; Proposal to Ban Powdered
Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable
Powder for Lubricating a Surgeon's Glove.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of

comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elizabeth Claverie-Williams, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 2508, Silver Spring, MD 20993,
301-796-6298, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. History of Powdered Gloves and Their Regulation
    B. Citizen Petitions
    C. Scope of the Ban
    D. Legal Standard
II. Evaluation of Data and Information Regarding Glove Powder
    A. Summary of Benefits for Devices That FDA Is Proposing To Ban
    B. Summary of Risks for Devices That FDA Is Proposing To Ban
    C. State of the Art
    D. Scientific Literature
    E. Actions of Other Regulatory Entities and Professional
Organizations
    F. Analysis of Medical Device Adverse Events Reported to FDA for
Medical Gloves
III. The Reasons FDA Initiated the Proceeding; Determination That
Powdered Gloves Present an Unreasonable and Substantial Risk of
Illness
IV. FDA's Determination That Labeling, or a Change in Labeling,
Cannot Correct or Eliminate the Risk
V. FDA's Determination That the Ban Applies to Devices Already in
Commercial Distribution and Sold to Ultimate Users, and the Reasons
for This Determination
VI. Legal Authority
VII. Environmental Impact
VIII. Economic Analysis of Impacts
    A. Introduction
    B. Summary
IX. Proposed Effective Date
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. References

I. Background

    The Medical Device Amendments of 1976 (Pub. L. 94-295) (the
amendments), amending the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 321 et seq.), became law on May 28, 1976. Among
other provisions, the amendments added section 516 to the FD&C Act (21
U.S.C. 360f), which authorizes FDA to ban by regulation any device
intended for human use if FDA finds, based on all available data and
information, that such device presents a ``substantial deception'' or
an ``unreasonable and substantial risk of illness or injury,'' which
cannot be, or has not been, corrected or eliminated by labeling or a
change in labeling.
    FDA is proposing to ban powdered surgeon's gloves (21 CFR
878.4460), powdered patient examination gloves (21 CFR 880.6250), and
absorbable powder for lubricating a surgeon's glove (21 CFR 878.4480).
Non-powdered gloves are not included in this ban. In order to clarify
this distinction, we are proposing to amend the descriptions of these
devices in the regulations to specify that, if the ban were to be
finalized, these regulations would apply only to non-powdered gloves.
FDA's conclusions, which are discussed in this document, are based on
an evaluation of all available data and information known to the
Agency. However, to the extent that there is additional information
that we should consider regarding the risks and benefits of powdered
gloves, comments should be submitted as described previously.
    The proposed rule would apply to all powdered gloves except
powdered radiographic protection gloves. FDA has determined that the
banning standard does not apply to this type of glove. In addition, we
are not aware of any powdered radiographic protection gloves that are
currently on the market. The proposed ban would not apply to powder
used in the manufacturing process (e.g., former-release powder) of non-
powdered gloves, where that powder is not intended to be part of the
final finished glove. Finished non-powdered gloves are expected to
include no more than trace amounts of residual powder from these
processes, and the Agency encourages manufacturers to ensure finished
non-powdered gloves have as little powder as possible. In our 2008
Medical Glove Guidance Manual (Ref. 1), we recommended that non-
powdered gloves have no more than 2 milligrams of residual powder and
debris per glove, as determined by the Association for Testing and
Materials (ASTM) D6124 test method (Ref. 2). The Agency continues to
believe this amount is an appropriate maximum level of residual powder,
but may reevaluate this amount if more information becomes available.
The proposed ban would also not apply to powder intended for use in or
on other medical devices, such as condoms. FDA has not seen evidence
that powder intended for use in or on other medical devices, such as
condoms, presents the same public health risks as that on powdered
medical gloves.

A. History of Powdered Gloves and Their Regulation

    Medical gloves play a significant role in the protection of both
patients and health care personnel in the United States. Health care
personnel rely on medical gloves as barriers against transmission of
infectious diseases and contaminants when conducting surgery, as well
as when conducting more limited interactions with patients.
    Various types of powder have been used to lubricate gloves so that
wearers could don the gloves more easily. The first lubricant powder
used to aid in surgical glove donning, introduced in the late
nineteenth century, was composed of Lycopodium spores (club moss
spores) or ground pine pollen (Refs. 3 and 4). By the 1930s, Lycopodium
powder was recognized to cause wound granulomas and adhesion formation
and was replaced by talcum powder (chemically hydrous magnesium
silicate), a nonabsorbable lubricant powder. In the 1940s, talcum
powder (talc) was also recognized to be a cause of postoperative
adhesions and granuloma formation. In 1947, modified cornstarch powder
was introduced as an absorbable and non-irritating glove powder, and it
largely replaced talc as a donning lubricant for surgical gloves by the
1970s. Cornstarch is currently the most commonly used type of
absorbable glove powder.
    In the 1980s, preventing the transmission of acquired
immunodeficiency syndrome (AIDS) became a major public health concern.
The Centers for Disease Control and Prevention (CDC) recommended that
health care workers use appropriate barrier precautions to prevent
exposure to the human immunodeficiency virus (HIV) and other bloodborne
pathogens. Responding to heightened concerns about cross-contamination
between patients and health care workers, in the Federal Register of
January 13, 1989 (54 FR 1602), FDA revoked the exemption for patient
examination gloves from certain current good manufacturing practice
requirements in order to ensure that manufacturers provide an
acceptable manufacturing quality level. FDA similarly revoked the
exemption from premarket notification

requirements for patient examination gloves.
    On December 12, 1990, FDA published regulations describing certain
circumstances under which surgeon's and patient examination gloves
would be considered adulterated (55 FR 51254). The regulations
established the sampling plans and test methods for glove leakage
defects that we would use to determine whether gloves were adulterated
(see 21 CFR 800.20). These sampling plans and test methods were further
updated in 2006 (December 19, 2006, 71 FR 75865 at 75876).
Subsequently, we initiated inspections of glove manufacturers to ensure
conformance with the acceptable quality levels identified in the
regulation.
    In 1997, FDA issued its Medical Glove Powder Report (Ref. 5), which
described the risks presented by glove powder and the state of the
medical glove market at that time. We reviewed the clinical and
experimental data on the risks and adverse events associated with the
use of powder on surgical and medical gloves available at that time in
the medical literature. We also reviewed the information in our
MedWatch database on the adverse events associated with the use of
powdered gloves. In addition, the Agency reviewed the commercial
information available at that time on sources for medical gloves,
relative numbers and types of gloves, and the costs of different glove
types. FDA found that glove powder could cause inflammation and
granulomas, and that aerosolized glove powder on natural rubber latex
(NRL) gloves can carry allergenic proteins that have the potential to
cause respiratory allergic reactions.
    Even though the Agency was aware of certain health risks presented
by glove powder, based on the totality of information available in
1997, the Agency opted not to initiate a ban. At the time, use of
chlorination was the most common alternative to powder for the purpose
of lubricating NRL surfaces. However, the chlorination process was
recognized to cause physical damage to gloves and to alter the physical
properties of treated gloves if not performed properly (Ref. 5). In
1997, FDA was concerned that widespread use of glove chlorination would
compromise some of the mechanical and physical properties of gloves
including shelf life, grip, and in-use durability, since these were
widely recognized risks of poorly managed chlorination processes.
Polymer coatings to replace glove powder for glove lubrication had been
developed but, because of their increased cost, were not yet in
widespread use at the time. The report concluded that banning powdered
gloves in 1997 would cause a market shortage of medical gloves, which
could result in inferior glove products and increased costs to the U.S.
health care system due to a lack of immediate availability of suitable
alternatives.
    We identified two options in 1997: (1) Provide adequate information
for the consumer to make an informed decision by, among other things,
requiring that the amount of water-soluble NRL proteins and the amount
of glove powder present in powdered gloves be stated on the product
label and establishing upper limits for the amount of these substances
allowed in gloves, or (2) initiate the process to ban glove powder at
some predetermined time in the future and require manufacturers to
convert to powder-free production or provide safety data, including
foreign body and airborne allergen concerns, by a certain date.
    At that time, the Agency determined that the first option was
preferable and issued the draft guidance entitled ``Draft Guidance for
Industry and FDA Staff: Medical Glove Guidance Manual'' on July 30,
1999 (Ref. 6). In addition to other changes, including the natural
rubber latex caution statement for gloves made of NRL, this document
advised industry that FDA recognized the newly issued consensus
standard ASTM D6124, ``Standard Test Method for Residual Powder on
Medical Gloves,'' which established an accepted method to measure
residual powder or debris on medical gloves (Ref. 2). In the draft
guidance, we recommended that medical gloves have no more than 2 mg of
residual powder or debris per glove in order to label that glove as
``powder-free.'' Since 1999, gloves with low amounts of residual powder
after manufacturing have been referred to as ``powder-free'' or
``powderless.'' Such gloves may have residual powder from the
manufacturing process removed by washing and chlorination, and they may
be coated with a polymer to aid donning. For comparison, powdered
medical gloves contain approximately 120 to 400 mg of residual
particulates, mold release, and donning powder.
    In addition to the draft guidance issued in 1999, in the same issue
of the Federal Register, FDA proposed regulations to reclassify all
surgeon's and patient examination gloves as class II medical devices
(July 30, 1999, 64 FR 41710). While the proposed rule was never
finalized, the preamble provided FDA's rationale for choosing not to
initiate a ban for powdered surgeon's and patient examination gloves at
the time. We explained that: (1) A ban would not address exposure to
natural latex allergens from medical gloves with high levels of natural
latex proteins; (2) a ban of powdered gloves might compromise the
availability of high quality medical gloves; and (3) a ban of powdered
gloves might greatly increase annual costs by almost as much as $64
million over the alternative approach proposed by FDA in the ``Draft
Guidance for Industry and FDA Staff: Medical Glove Guidance Manual.''
    FDA did not finalize the 1999 Draft Guidance. The Draft Guidance
was withdrawn when we issued our ``Guidance for Industry and FDA
Staff--Medical Glove Guidance Manual,'' on January 22, 2008 (Ref. 1).
Recognition and use of ASTM D6124 to reduce the powder burden on
medical gloves continued in the revised guidance. Since we issued the
draft guidance in 1999, the number of adverse events reported to FDA
related to glove use and the number of powdered glove devices seeking
premarket clearance have decreased.

B. Citizen Petitions

    FDA has received several citizen petitions regarding the use of
glove powder. In 1998, a citizen petition was submitted by Public
Citizen requesting that FDA ban the use of cornstarch powder in the
manufacture of latex surgeon's and patient examination gloves (see
Docket No. FDA-2008-P-0531). While there was scientific evidence in
1998 that indicated that the use of glove powder was associated with
negative health consequences (partly due to the ability of glove powder
to facilitate sensitization of health care workers to NRL and partly
due to adverse effects due only to contact with glove powder), as
discussed previously, quality concerns, the lack of suitable
alternatives, and costs weighed against FDA initiating the process to
remove powdered gloves from the market. Moreover, the impact of
reductions in the amount of NRL protein used in gloves and in the
amount of powder added to gloves, which were being done as means to
mitigate the risk of health care worker sensitization to NRL, had not
yet been studied for a reasonable length of time. As a result of these
considerations, we did not grant the 1998 petition to ban the use of
glove powder.
    Approximately a decade later, between 2008 and 2011, FDA received
three petitions requesting, among other things, that the Agency ban the
use of cornstarch powder on NRL and synthetic latex surgical and
examination gloves (FDA-2008-P-0531-0001, FDA-2009-P-0117-0001, and
FDA-2011-P-

0331-0001). These petitions prompted us to evaluate new data on the
risks of using powdered gloves, to consider new information regarding
the current availability and costs of alternatives to glove powder for
glove lubrication, and to reassess the frequency of use of powdered
medical gloves. As a result of these petitions, FDA published in 2011
in the Federal Register a document requesting comments related to the
risks and benefits of powdered gloves (February 7, 2011, 76 FR 6684;
FDA-2011-N-0027). In addition, although we believed that additional
labeling would not correct or eliminate the risks associated with glove
powder, we decided that it was important to inform consumers about the
risks of powdered gloves while FDA assessed whether glove powder had
benefits that might affect the determination of whether or not a ban on
the devices was appropriate at this time. Accordingly, on February 7,
2011, FDA issued the draft guidance entitled ``Draft Guidance for
Industry and FDA Staff: Recommended Warning for Surgeon's Gloves and
Patient Examination Gloves that Use Powder,'' which proposed a general
voluntary warning for powdered glove devices, regardless of whether the
devices were surgeon's gloves or patient examination gloves (Ref. 7).
As we reviewed the comments received on the benefits and risks of glove
powder, we determined that a ban on powdered gloves is appropriate and
determined not to finalize the draft guidance. This draft guidance was
withdrawn on May 6, 2015 (80 FR 26059) as part of a mass withdrawal
effort to remove draft guidance documents issued before 2014 that have
not been finalized. When final, this rule will address the risks of
powdered gloves that were addressed in the draft guidance.

C. Scope of the Ban

    FDA is proposing to ban the following devices: (1) Powdered
surgeon's gloves (21 CFR 878.4460), (2) powdered patient examination
gloves (21 CFR 880.6250), and (3) absorbable powder for lubricating a
surgeon's glove (21 CFR 878.4480).
    Because the classification regulations for these device types do
not distinguish between powdered and non-powdered versions, FDA is
proposing to amend the descriptions of these devices in the regulations
to specify that, if this proposed ban is finalized, these regulations
will apply only to non-powdered gloves while the powdered version of
each type of glove will be added to 21 CFR 895 Subpart B--Listing of
Banned Devices.

D. Legal Standard

    Section 516(a)(1) of the FD&C Act authorizes FDA to ban a device
intended for human use by regulation if it finds, on the basis of all
available data and information, that such a device ``presents
substantial deception or an unreasonable and substantial risk of
illness or injury.'' A banned device is adulterated under section
501(g) of the FD&C Act (21 U.S.C. 351(g)).
    In determining whether a deception or risk of illness or injury is
``substantial,'' FDA will consider whether the risk posed by the
continued marketing of the device, or continued marketing of the device
as presently labeled, is important, material, or significant in
relation to the benefit to the public health from its continued
marketing (see 21 CFR 895.21(a)(1)). Although FDA's device banning
regulations do not define ``unreasonable risk,'' in the preamble to the
final rule promulgating 21 CFR part 895, we explained that, with
respect to ``unreasonable risk,'' it ``will conduct a careful analysis
of risks associated with the use of the device relative to the state of
the art and the potential hazard to patients and users'' (44 FR 29214
at 29215, May 18, 1979). The state of the art with respect to this
proposed rule relates to current technical and scientific knowledge and
medical practice as it pertains to the various medical gloves that are
used when treating patients.
    Thus, in determining whether a device presents an ``unreasonable
and substantial risk of illness or injury,'' FDA analyzes the risks and
the benefits the device poses to patients and, in the case of powdered
gloves, other individuals who come in contact with these devices, by
comparing those risks and benefits to the risks and benefits posed by
alternative devices and/or treatments being used in current medical
practice. Actual proof of illness or injury is not required; we need
only find that a device presents the requisite degree of risk on the
basis of all available data and information (H. Rep. 94-853 at 19; 44
FR 29215).
    Whenever FDA finds, on the basis of all available data and
information, that the device presents substantial deception or an
unreasonable and substantial risk of illness or injury, and that such
deception or risk cannot be, or has not been, corrected or eliminated
by labeling or by a change in labeling, FDA may initiate a proceeding
to ban the device (see 21 CFR 895.20). If FDA determines that the risk
can be corrected through labeling, FDA will notify the responsible
person of the required labeling or change in labeling necessary to
eliminate or correct such risk (see 21 CFR 895.25).
    Section 895.21(d) requires this proposed rule to summarize: (1) The
Agency's findings regarding substantial deception or the unreasonable
and substantial risk of illness or injury; (2) the reasons why FDA
initiated the proceeding; (3) the evaluation of the data and
information FDA obtained under provisions (other than section 516) of
the FD&C Act, as well as information submitted by the device
manufacturer, distributer, or importer, or any other interested party;
(4) the consultation with the classification panel; (5) the
determination that labeling, or a change in labeling, cannot correct or
eliminate the deception or risk; (6) the determination of whether, and
the reasons why, the ban should apply to devices already in commercial
distribution, sold to ultimate users, or both; and (7) any other data
and information that FDA believes are pertinent to the proceeding.
    We have grouped some of these together within broader categories
and address them in the following order:
     Evaluation of data and information regarding glove powder,
including data and information FDA obtained under provisions other than
section 516 of the FD&C Act, information submitted by the device
manufacturer and other interested parties, the consultation with the
classification panel, and other data and information that FDA believes
are pertinent to the proceeding, with respect to:

[cir] Benefits
[cir] Risks
[cir] State of the Art

     The reasons FDA initiated the proceeding, our
determination that glove powder presents an unreasonable and
substantial risk of illness or injury (FDA has not made a finding
regarding substantial deception);
     FDA's determination that labeling, or a change in
labeling, cannot correct or eliminate the risk; and
     FDA's determination that the ban applies to devices
already in commercial distribution and sold to ultimate users, and the
reasons for this determination.

II. Evaluation of Data and Information Regarding Glove Powder

    A thorough review of the information that has become available
since FDA issued the Medical Glove Powder Report in 1997 (Ref. 5)
supports FDA's conclusion that powdered surgeon's gloves, powdered
patient examination gloves, and absorbable powder for

lubricating a surgeon's glove should be banned. As discussed in the
paragraphs that follow, FDA has concluded that the risks posed by
powdered gloves, including health care worker and patient sensitization
to NRL allergens, surgical complications related to peritoneal
adhesions, and other adverse health events not necessarily related to
surgery, such as inflammatory responses to glove powder, outweigh the
benefits that these devices pose to patients. FDA's position is
bolstered when the state of the art for medical gloves is considered,
which includes viable non-powdered alternatives that do not carry any
of the risks associated with glove powder. Further, unlike when this
decision was considered previously, FDA believes that this ban would
likely have minimal economic and shortage impact on the health care
industry. Thus, a transition to alternatives in the marketplace should
not result in any detriment to public health.
    In reaching the conclusions that form the basis for this proposed
rule, FDA considered evidence from multiple sources. FDA re-examined
the 1997 Report on Medical Glove Powder (Ref. 5) along with its
scientific and clinical literature references, its analysis of reported
adverse events due to the use of gloves, and its analysis of glove
market availability (Ref. 5). In addition, we performed a more
contemporary analysis of relevant scientific literature and of adverse
events related to medical glove use from 1992 through 2014 and obtained
new market availability data on medical glove use by type. We also
reviewed the information contained in related citizen petitions, as
well as the comments associated with the petitions. Further, the Agency
reviewed the public statements and actions of other U.S. government
Agencies, U.S. health care organizations, and of foreign governments
concerning powdered natural rubber latex gloves.
    The sections that follow discuss the information that FDA evaluated
as part of the decision to propose this ban. Sections II.A and II.B
provide a concise summary of the benefits and risks that FDA believes
are posed by the use of powdered gloves. Section II.C provides a
discussion on the state of the art as it pertains to medical gloves.
Sections II.D, II.E, and II.F provide detailed discussions of the
scientific literature, actions of other regulatory and professional
organizations, and adverse event reports that formed the basis of the
summaries in sections II.A and II.B.

A. Summary of Benefits for Devices That FDA Is Proposing To Ban

    To help determine whether powdered gloves present an unreasonable
and substantial risk of illness or injury, FDA issued a notice in the
Federal Register requesting public input on the risks and benefits of
powdered gloves (February 7, 2011, 76 FR 6684; FDA-2011-N-0027). FDA
received nearly 300 comments to the docket, the large majority of which
addressed the continuing risks associated with the use of powdered
gloves, which are discussed later in this document. Comparatively, very
few comments addressed the benefits of gloves that are powdered, and
the benefits that were addressed were minimal. The primary benefits
described in the comments were almost entirely related to greater ease
of donning and doffing gloves and decreased tackiness of gloves
packaged together. These benefits apply to both powdered surgeon's
gloves and powdered patient examination gloves. The benefits of
absorbable powder for lubricating a surgeon's glove derive from the
benefits of powdered surgeon's gloves, which include ease of donning
and doffing gloves and decreased tackiness.
    Some studies have reported that alternatives to powdered gloves,
such as vinyl gloves, may not provide as good of dexterity and
biological impermeability as NRL gloves (Ref. 8). However, this
proposed ban does not include non-powdered NRL gloves, which offer the
same performance characteristics of powdered NRL gloves, and several
studies have found that alternatives, such as nitrile and neoprene
gloves, offer the same level of protection, dexterity, and performance
as NRL gloves (Ref. 9 to 14). Thus, the only benefits to using powdered
gloves that FDA has been able to identify is a greater ease of donning
and doffing and decreased tackiness of gloves packaged together.

B. Summary of Risks for Devices That FDA Is Proposing To Ban

    Although some risks of these devices are similar for all glove
types, the level and types of risks presented by powdered gloves can
vary depending on the composition of the glove (synthetic versus NRL)
and its indicated uses (surgeon's glove versus patient examination
glove). While we acknowledge that powdered synthetic patient
examination gloves present less risk than powdered NRL surgeon's
gloves, we concluded that the risks posed by either of these glove
types is unreasonable and substantial in relation to the minimal
benefits that powdered gloves offer, especially when considering the
benefits and risks posed by readily available alternative devices
(discussed in section II.C). The identified risks of powdered gloves
are as follows:
1. Risks of Absorbable Powder for Lubricating a Surgeon's Glove
    The powder used for lubricating a surgeon's glove, which is often
used to lubricate patient examination gloves as well, presents risks
not only to the user and patient, but also to other individuals that
might be exposed to it. This powder, often referred to as Absorbable
Dusting Powder or ADP, has been shown to cause acute severe airway
inflammation, granulomas, and adhesions. These risks are present before
the glove is lubricated with the powder. Then, during the lubrication
process, the powder particles may absorb harmful contaminants (Ref.
15). As mentioned previously, the risks presented by glove powder can
vary depending on the type of glove on which it is used. When used on
NRL gloves, powder has the ability to adhere to latex allergenic
proteins that, when aerosolized and inhaled, present significant risks
to patients, including inflammatory responses, hypersensitivity
reactions, and allergic reactions (see risks on powdered NRL gloves in
the paragraphs that follow). Additionally, latex sensitive individuals
can experience cutaneous reactions upon skin exposure to the latex
allergenic proteins adherent to the powder (Refs. 15 and 16). These
consequences of powder may persist even after patients or health care
workers are no longer in contact with the powder. Risks such as
allergic reactions, granulomas, and adhesions can be long-lasting, and
may not be mitigated by removing powder after exposure (Refs 17 to 19).
2. Risks of Powdered Natural Rubber Latex Gloves
    When absorbable dusting powder is used on NRL gloves, the
combination presents specific risks that apply to both surgeon's and
patient examination gloves. The powder used to lubricate these gloves
may bind to natural rubber latex proteins. The powder carries the latex
protein, resulting in a latex aerosol whenever health care workers put
on or remove the gloves. Clinical and laboratory studies indicate that
glove powder facilitates impaired respiratory function due to allergic
and inflammatory responses to NRL in health care personnel and in
animals exposed to glove powder because

aerosolized powder particles carrying NRL antigens into the health care
environment and the respiratory tracts of exposed health care personnel
and patients make NRL sensitization a much more efficient process than
it would be in the absence of glove powder (Ref. 8, 20 to 23). As a
result, health care workers that are sensitive to latex occasionally
develop allergic reactions when they inhale too much powder.
Sensitization to latex and subsequent allergic reactions also may
result from exposure to aerosolized powder carrying the NRL proteins
(Ref. 24). Allergic reactions include asthma, allergic rhinitis,
conjunctivitis, and dyspnea. As discussed in the paragraphs that
follow, the majority of studies suggest that use of low NRL protein
powder-free gloves significantly reduces occupational asthma and the
incidence of individuals developing allergies to NRL in the health care
workplace (Refs. 21, 23, 25 to 35).
3. Risks of Powdered Synthetic Surgeon's Gloves
    Although powdered synthetic surgeon's gloves do not present the
risk of allergic reactions due to aerosolized powder that is carrying
latex, the use of powdered synthetic gloves still presents the risk of
exposing individuals to the powder via inhalation, which can lead to
airway inflammation. Additionally, use of these gloves by health care
providers can expose patients' tissues during surgery and invasive
examinations to deposits of glove powder, which could then result in
granuloma formation in any exposed site, as well as peritoneal and
other tissues adhesions. Recent studies show that cornstarch glove
powder causes peritoneal adhesion formation and granulomatous reactions
in experimental animal models (Refs. 24, 36 to 39) as well as in
exposed patient tissues with resulting patient injury (Refs. 40 and
41). In addition to risk of powder-induced adhesion formation, many in
vitro and animal studies have shown the adverse effects of glove powder
on wound healing, including increases in wound inflammation (Refs. 42
to 44). These studies indicate that powder may promote infection in
wounds, which can lead to wound healing complications.
4. Risks of Powdered Synthetic Patient Examination Gloves
    Although the powder on patient examination gloves is not exposed to
internal organs during surgery, these gloves still present a
substantial risk of illness or injury because they are nevertheless
exposed to internal tissue when employed in procedures such as oral,
vaginal, gynecological, and rectal examinations. Powder may be
introduced to the female reproductive tract during gynecological exams
(Refs. 45 to 47), which may lead to female reproductive complications
(Refs. 18, 48 to 50). The migration of powder into the reproductive
tract was demonstrated in an animal model and human clinical studies
(Refs. 21, 40, 51). The wearers of these gloves can also facilitate the
migration of powder from these gloves into the body when handling
instruments such as endoscopes or when performing postsurgical wound
care. Thus, the powder on synthetic patient exam gloves presents risks
similar to those of the powder on synthetic surgeon's gloves, including
granulomas and adhesions, and the resulting complications. Finally, as
with synthetic surgeon's gloves, powdered patient examination gloves
also can expose those in their proximity to the risk of powder
inhalation, even if not carrying NRL.

C. State of the Art

    FDA has considered the reasonableness of the risks of powdered
surgeon's gloves, powdered patient examination gloves, and absorbable
powder for lubricating a surgeon's gloves relative to the state of the
art, i.e., the state of technical and scientific knowledge and modern
practices of medicine, for medical protective gloves (see 44 FR 29214;
May 18, 1979). Given that alternatives are readily available that do
not carry the risks posed by powdered gloves, we have concluded that
powdered gloves now lag behind the state of the art. As discussed
further in sections II.D and II.E, this conclusion is illustrated both
by market trends indicating that the health care industry is moving to
non-powdered alternatives and by the actions of certain regulatory
entities and professional organizations that have banned or restricted
the use of glove powder.
    Over the last two decades FDA has observed a progressive increase
in the use of non-powdered gloves. Since 1998, medical glove
manufacturers have developed a variety of non-powdered gloves, which
can be made from various materials, including NRL, polyvinyl chloride,
nitrile, and neoprene. Both non-powdered patient examination and non-
powdered surgeon's gloves are currently marketed. These alternatives
are readily available at similar costs to powdered gloves. As a result,
both industry and glove users appear to be shifting away from the use
of powdered gloves, which has led to an increase in the manufacturing
and usage of alternative non-powdered gloves. Annual sales figures from
2000 through 2008 indicate a consistent increase in non-powdered
surgeon's and patient examination glove sales as a percent of total
glove sales, and recent projections of annual gloves sales indicate
that at least 93 percent of medical providers have switched to non-
powdered gloves (Ref. 52).
    These trends can be at least partially attributed to scientific
studies that have been conducted in this area that have helped raise
public awareness of powder-induced latex hypersensitivity, peritoneal
adhesions, granulomas, and other adverse events that can result from
using powdered gloves. These trends can also be partially attributed to
increased public awareness resulting from the availability of studies
that have examined the effects of glove powder and the public health
benefits that result from its removal from the market, along with
industry initiatives to improve donning, doffing, and protection of
non-powdered gloves, which have helped to move the state of the art
forward to the use of alternative non-powdered gloves.
    As described previously, some users of powdered gloves have noted
ease of donning or doffing as a benefit over non-powdered gloves.
However, a study of various brands of powdered and non-powdered NRL
gloves by Cote et al. found that there are non-powdered latex gloves
that are easily donned with wet or dry hands with relatively low force
compared to the forces required to don powdered latex examination
gloves (Ref. 53). Additional non-powdered alternatives to powdered
gloves include synthetic gloves, which are traditionally non-powdered
and offer similar levels of performance to powdered gloves and non-
powdered NRL gloves (Refs. 9, 14, 54).
    Studies that have examined the effects of removing powdered gloves
from health care environments have shown that removing these devices
consistently results in a reduction of the types of adverse events
associated with glove powder. Korniewicz et al. examined the effect of
conversion from powdered NRL surgical gloves to non-powdered NRL
surgical gloves on operating room personnel (Ref. 32). This study found
that conversion to non-powdered NRL gloves reduced adverse events
related to exposure to NRL, including a significant decrease in skin
and upper respiratory symptoms. During the course of the study, the
authors also evaluated user satisfaction for non-powdered gloves and
found that users rated their satisfaction, on average, the same or
better than before conversion from powdered gloves to non-powdered

gloves in categories including quality, comfort, safety, performance,
standardization, and needle stick injuries.
    In another study on the effects of eliminating powdered NRL gloves
from a hospital, Allmers et al. found that eliminating powdered NRL
gloves reduced aerogenic NRL allergen loads and allowed latex-
sensitized or latex-allergic health care workers to continue working
(Ref. 25). Allmers et al. further assessed the effects of switching to
non-powdered NRL gloves on the incidence of NRL allergy in personnel
working in multiple health care facilities insured by the German
Professional Association for Health Services and Welfare (Ref. 27).
This study concluded that there was a significant correlation between
an increase in the purchase of non-powdered NRL gloves and a decline in
NRL-induced occupational asthma. In a subsequent study, Allmers et al.
further showed that a reduction in the use of powdered NRL gloves
correlated with a dramatic decline in reported NRL-induced occupational
skin disease (Ref. 26). The authors of these studies concluded that
removing powdered NRL gloves from health care environments successfully
reduced the development of NRL-induced allergies. These observations
have been confirmed by several other studies that are described further
in section II.D (Refs. 21, 30, 32 to 35, 55).
    FDA also expects that the removal of powdered gloves from health
care environments will reduce the risks of using powdered synthetic
gloves, such as granuloma formation in any exposed site, as well as
peritoneal and other tissues adhesions. As discussed previously, recent
literature has shown that cornstarch glove powder causes peritoneal
adhesion formation and granulomatous reactions in experimental animal
models (Refs. 24, 36 to 39) as well as in exposed patient tissues with
resulting patient injury (Refs. 40 and 41). In addition to risk of
powder-induced adhesion formation, many in vitro and animal studies
have shown the adverse effects of glove powder on wound healing,
including increases in wound inflammation (Refs. 42 to 44). Non-
powdered gloves do not carry these risks, and their exclusive use
should greatly reduce the risk of these adverse health effects in
health care settings.
    In comparison to the evidence considered in 1997, FDA has concluded
that this proposed ban would likely have minimal economic and shortage
impact on the health care industry, such that, if they have not
already, health care entities that currently use powdered gloves should
have little trouble transitioning to non-powdered alternatives. As
described previously, there are many readily available alternatives to
powdered gloves that provide similar or better protection and utility
without the risks associated with powdered gloves, and available market
projections and data have shown that these alternatives that represent
the state of the art have already resulted in a shift away from
powdered gloves. Further, more studies are now available on the
positive health benefits associated with the restriction or elimination
of the use of powdered gloves in health care environments where they
were previously prevalent. Based on an examination of all these
factors, FDA has determined that the state of the art, i.e., the state
of technical and scientific knowledge and modern practices of medicine,
has moved beyond the use of powdered gloves in the health care
industry.

D. Scientific Literature

    In 1997, FDA issued the Medical Glove Powder Report (Ref. 5),
discussing the potential adverse health effects of medical glove
powder, along with alternatives and market information available at
that time. Adverse health events documented in the scientific
literature review section of the Medical Glove Powder Report included a
discussion on aerosolized glove powder on NRL gloves carrying
allergenic proteins that efficiently sensitized health care providers
to NRL antigens. This exposure subsequently triggered respiratory
allergic reactions including asthma and allergic rhinitis,
conjunctivitis, and dyspnea. In addition, as discussed previously, the
powdered gloves of health care providers expose patients to certain
risks, including granuloma formation, as well as peritoneal and other
tissue adhesions when exposed during surgery or an invasive procedure.
    Since the publication of the Medical Glove Powder Report, there
have been additional scientific studies published regarding the risks
related to the use of medical glove powder. Many of these references
were submitted to the Agency in support of the petitions received in
2008, 2009, and 2011. We also performed our own review of the
scientific literature to ensure that all available evidence, including
all available scientific evidence, was considered in its decision-
making process. The most relevant articles gathered from these sources
are briefly summarized in this document.
    Clinical and laboratory studies published after 1998 still indicate
that glove powder facilitates impaired respiratory function due to
allergic and inflammatory responses to NRL in health care personnel and
in animals exposed to glove powder because aerosolized powder particles
carrying NRL antigens into the health care environment and the
respiratory tracts of exposed health care personnel and patients make
NRL sensitization a much more efficient process than it would be in the
absence of glove powder (Refs. 8, 20 to 23). The newer studies also
continue to show that cornstarch glove powder causes adhesion formation
and granulomatous reactions in experimental animal models (Refs. 24, 36
to 39), as well as in exposed patient tissues with resulting patient
injury (Refs. 40 and 41).
    In vitro and animal studies continue to show the adverse effects of
glove powder on experimental wound healing, including increases in
wound inflammation (Refs. 42 to 44). Most importantly, since 1997, more
data have become available on the positive health benefits associated
with the restriction or elimination of the use of powdered gloves in
health care environments where they were previously permitted. We
reviewed studies from clinics and hospitals that have converted to
either non-powdered NRL gloves or to powder-free gloves of all
materials. These studies reported reductions in NRL allergy development
and respiratory symptoms among health care workers (Refs. 20, 21, 23,
25 to 27, 29 to 34, 39). Although this has not been a universal
finding, FDA recognizes the positive association between decreased
usage of glove powder, especially on NRL gloves, and decreased adverse
health events in the health care setting.
    Epidemiological studies comparing the adverse health events and
economic consequences in health care settings before and after
conversion to powder-free gloves have limitations, such as the size of
studies, the endpoint data collected, and the different populations
studied. Some studies include the period before the amount of NRL
protein in surgical and examination gloves was reduced. Others were
performed abroad where U.S. regulations do not apply and the amounts of
NRL protein and powder remaining on gloves are not stated. Despite
these limitations, the preponderance of evidence suggests that use of
low NRL protein powder-free gloves significantly reduces occupational
asthma and the incidence of individuals developing allergies to NRL in
the health care workplace (Refs. 20, 21, 23, 25 to 27, 29 to 34, 39).
Importantly, these studies did not report

difficulty in replacing powdered gloves with non-powdered ones and did
not note any decrease in glove performance in the replacement gloves
(Refs. 32, 53).
    Charous et al. (Ref. 20) reported in 2000 that a dental office was
able to reduce airborne NRL antigen levels to undetectable levels with
the exclusive use of non-powdered NRL gloves, permitting a highly
sensitized staff member to continue to work there. Also in 2002, Kujala
et al. (Ref. 22) studied NRL gloves agitated in laboratory test
chambers and found that the concentration of airborne NRL allergens
correlated with high levels of airborne glove powder rather than with
the NRL antigen concentrations in the medical glove material. In
addition, Ahmed et al. (Ref. 8) reviewed the literature to 2004 on
occupational NRL allergy and concluded that the use of low NRL protein
powder-free gloves reduced symptoms and markers of sensitization in
hospitals that had removed powdered NRL gloves from their workplaces;
however, they noted that alternatives such as nitrile and vinyl gloves
may not provide as good dexterity and biological impermeability as
natural rubber latex gloves. The practicality of using non-powdered
gloves was studied in 1998 by Cote et al. (Ref. 53) who performed a
prospective randomized trial measuring the force required for
volunteers to don various gloves in the laboratory without tearing the
glove. They concluded that there were available powder-free gloves that
can be donned easily with forces that are comparable to those required
for powdered glove donning.
    Individual hospitals, health care systems, regional authorities and
countries have evaluated the extent of NRL allergies among their staff
and the effects of removing glove powder from the gloves used in their
facilities. In 1998, Handfield-Jones (Ref. 56) found that at least 0.9
percent of health care workers in an English district general hospital
had confirmable NRL allergies. Anecdotal accounts suggested that
problems had worsened as glove use increased. Allmers et al. (Ref. 25)
in 1998 reported a prospective study in a single hospital in Germany to
evaluate the effect of eliminating powdered NRL gloves from the
workplace and also giving NRL-free gloves to sensitized workers. Six of
seven sensitized health care workers showed a decrease in NRL-specific
Immunoglobulin E antibody concentration during followup after the
elimination of powdered NRL gloves in that hospital. Two other health
care workers were able to stop using asthma medication and antiallergic
drugs. The study authors concluded that eliminating powdered NRL gloves
reduced aerogenic NRL allergen loads and allowed sensitized or allergic
health care workers to continue working.
    Not every physician or locality was equally concerned about the
risk associated with the use of glove powder. In 1999, Sellar and
Sparrow (Ref. 57) surveyed ophthalmologists in northern England and
found that, despite relatively high awareness of risks associated with
powdered glove use during ophthalmic surgery, such as sterile
endophthalmitis or iritis in patients, up to 15 percent of surveyed
United Kingdom ophthalmic surgeons were using powdered gloves in their
surgical practices. However, in 2000, Petsonk (Ref. 58) found that the
role of glove powder in binding and transferring NRL antigens was
widely acknowledged in the scientific literature and noted that
interventions, such as limiting the use of glove powder, seemed likely
to result in a decline in the prevalence of NRL allergies.
Additionally, in 2000, Jackson et al. (Ref. 31) reported that 70
hospitals in the United States and 3 in Europe had registered on an
Internet Web site as institutions using only powder-free gloves;
however, the article did not specify whether these hospitals had
removed only NRL powdered gloves from their workplaces or whether
synthetic latex powdered gloves were removed from use as well, and the
Web site is no longer registered. The conclusion of Jackson et al. was
that the leadership shown by the hospitals that registered as not using
powdered gloves should serve as a catalyst for FDA to ban the use of
cornstarch on examination and surgical gloves.
    In 2001, Liss and Tarlo (Ref. 33) reviewed the number of allowed
occupational asthma claims in health care workers reported to the
Ontario Workplace Safety and Insurance Board over time as the
replacement use of powder-free synthetic latex or low protein NRL
gloves was encouraged, starting in 1996, throughout the province of
Ontario. Reported health care-related occupational asthma claims ranged
from 7 to 11 per year during 1991 to 1994 and fell to 1 to 2 claims per
year in 1997 to 1999 as exposure to powdered NRL gloves decreased.
Tarlo et al. (Ref. 55) also reported on the experience with
occupational allergy to NRL in an Ontario teaching hospital network of
two hospitals. In this hospital system, the number of workers
identified with NRL allergy each year rose from 1 in 1988 to 6 in 1993
and to 25 in 1994 after staff education and surveillance for the
manifestations of NRL allergy. Powder-free, low protein NRL gloves
replaced non-sterile gloves in 1995 in this hospital system, after
which new workers with reported NRL allergy dropped to eight in 1995,
to three in 1997 and to one in 1999. NRL allergy-related time lost from
work and workers' compensation claims fell significantly after powder-
free, low protein NRL gloves replaced powdered non-sterile gloves in
this Ontario hospital system. In 2002, Saary et al. (Ref. 23)
resurveyed the upper-year students and faculty of a dental school in
Ontario for NRL allergy using the same methods as those used in the
study performed by Tarlo et al. (Ref. 55). In 1995, the school was
using powdered NRL gloves in patient care. Following the 1995 survey,
the school changed to powder-free, low protein NRL gloves. In 2000, the
incidence of positive prick tests to NRL fell from 10 percent (in 1995)
to 3 percent and there were significant reductions in the incidence of
urticaria and immediate pruritus after glove contact reported by the
dental students.
    Allmers et al. (Ref. 27) reported in 2002 occupational allergy to
NRL data from the German Professional Association for Health Services
and Welfare, which covered approximately half of all German hospitals
and all dental offices. In 1998, Germany banned the use of powdered NRL
gloves in health care facilities. From 1996 through 2001, the incidence
of suspected occupational NRL allergy declined steadily as the use of
powder-free NRL examination gloves and powder-free NRL sterile gloves
overtook the use of powdered gloves in 1998 and 2000, respectively, in
German acute care hospitals. The authors concluded that primary
prevention of occupational NRL allergies could be achieved through
practical interventions such as decreasing the use of powdered NRL
gloves. Allmers et al. (Ref. 26) reassessed the effects of the 1998
German ban on powdered NRL gloves in 2004 and found that between 1996
and 2002, the incidence of suspected cases of NRL-induced occupational
allergies reported to the German statutory accident insurance carrier
decreased by almost 80 percent.
    Charous et al. (Ref. 28) reviewed the scientific literature
available in 2002 and subsequently recommended using only non-powdered
sterile NRL gloves or low-protein NRL powdered sterile gloves as
evaluation of the effect on occupational NRL allergic reactions
continued, in order to reduce the burden of NRL allergy and its effects
on health care personnel. Cuming (Ref. 29) also noted that the link
between glove powder and the occurrence of NRL allergies and
postoperative

complications in surgical patients was well supported scientifically
and described how his four hospital system (not identified) with
multiple ambulatory care centers and associated medical practices
successfully eliminated powdered glove use after appropriate alternate
glove product evaluation.
    Edelstam and colleagues (Ref. 21) described the implementation of a
powder-free environment in a Stockholm hospital. These authors
administered symptom questionnaires to hospital staff designed to
detect symptoms highly suggestive of occupational NRL allergy. They
found that 8 months after a powder-free policy was fully implemented in
the hospital there was a significant reduction in reported hand
itching, eczema, and upper respiratory tract disorders in health care
workers. The authors also noted that reduced costs associated with
lower work absence rates may offset higher costs associated with the
use of powder-free medical gloves.
    In 2005, Korniewicz et al. (Ref. 32) examined whether switching to
low NRL protein powder-free surgical gloves in the operating room suite
of a single U.S. university hospital was worth the cost. Surveys prior
to and 7 to 12 months after the conversion to powder-free surgical
gloves found that 27 percent fewer health care workers reported skin
symptoms and 12 percent fewer health care works reported upper
respiratory symptoms related to NRL exposure. These authors concluded
that the use of powder-free low protein NRL gloves reduced symptoms and
resulted in workers compensation cost savings. In addition, because
fewer different types of gloves were purchased after the conversion to
non-powdered surgical gloves, a glove cost savings of $10,000 per year
was estimated for the hospital. In a 2006 report, Filon and Radman
(Ref. 30) described the results of following 1,040 health care workers
in Trieste for 3 years before and after the introduction of powder-free
gloves with low NRL levels. After the introduction of powder-free
gloves, no new cases of NRL allergy, as diagnosed by skin test
hypersensitivity to NRL were identified in the followup survey. The
authors concluded that avoiding unnecessary NRL glove use and using
non-powdered NRL gloves (and non-NRL gloves for sensitized health care
workers) could stop the progression of symptoms of NRL allergy and
avoid new cases of health care provider sensitization to NRL.
    In 2008, Malerich et al. (Ref. 34) studied the effect of
transitioning from powdered to powder-free NRL gloves on workers'
compensation claims in a U.S. multihospital system, the Geisinger
Health System, between 1997 and 2005. They estimated that 52 percent of
the system work force at that time was occupationally exposed to NRL
gloves. In 2001, the system transitioned to powder-free NRL gloves. The
incidence of NRL-related workers' compensation claims decreased
progressively after 2001, from 62 claims over the 5 year period before
the change to only 18 claims in the next 4 years. The average annual
savings in NRL-related compensation claims was estimated to be over
$30,000. Although the cost of the powder-free NRL gloves resulted in a
36 percent increase in the cost of gloves, this was partially offset by
the elimination of the costs of washing powder off the surgical gloves,
estimated at about $57,000.
    Vandenplas et al. (Ref. 35) reported in 2009 on changes in the
incidence of NRL-related occupational asthma (OA) claims from health
care providers submitted to the Workers' Compensation Board of Belgium
from 1992 through 2004. Definite and probable NRL-related OA incidence
per 100,000 full-time equivalents for health care workers was 10.9 per
100,000 in 1991, 19.7 per 100,000 in 1998, and 3.8 per 1,000,000 in
2003. The overall usage index of NRL-powdered glove use was 80.9
percent in 1989 and fell to 17.9 percent by 2004. The non-sterile NRL-
powdered glove use index fell from 80.5 percent to 14.4 percent.
However, the sterile procedure, NRL-powdered glove use index changed
only from 84.6 percent to 48.9 percent over this 15-year period.
    Although the adverse event risks of glove powder on a variety of
tissues were well-documented before 1997, investigations to understand
the pathogenesis of tissue damage caused by glove powder have
continued. In 1999, Chegini and Rong (Ref. 36) studied the effect of
glove powder, NRL proteins, and lipopolysaccharide added directly to
the peritoneal cavity of mice and found that glove powder worsened the
inflammatory response to tissue injury caused by NRL proteins and
lipopolysaccharide alone. The study suggested that this interaction
could contribute to inflammatory or immune reactions and the
development of adhesions after abdominal surgery. Sj[ouml]sten et al.
(Ref. 38) published a study in 2000 showing that the intravaginal
deposition of free glove powder in rabbit vaginas prior to laparotomy
led to dense pelvic adhesions and even attachment of the Fallopian tube
to the peritoneal wall after laparotomy with standardized trauma on the
left Fallopian tube and the ipsilateral peritoneum. The control group
was not exposed to glove powder and experienced only loose adhesions
after laparotomy with standardized trauma. The authors recommended
against the use of powdered gloves during gynecologic surgery.
    In 2001, van den Tol et al. (Ref. 39) found that starch, either
washed from gloves or pure base starch, when added to the peritoneal
cavity of rats during laparotomy plus surgical peritoneal trauma,
caused increased peritoneal adhesion formation. When tumor cells were
added to the peritoneal cavity at the end of the experimental surgery,
increased adhesion and growth of the tumor cells occurred in rats who
also received powder contamination of the peritoneal cavity. These
authors recommended that powdered gloves no longer be used during
intra-abdominal surgery on the basis of these results. In 2003, Barbara
et al. (Ref. 24) found that after guinea pigs were sensitized to NRL
antigens, with or without added cornstarch powder given by
intraperitoneal injection, the guinea pigs who received NRL antigens
mixed with cornstarch had increased antibody production and antigen-
induced constriction of the bronchial tubes when challenged with an
aerosol of NRL antigens compared to animals who received
intraperitoneal NRL antigens alone. They concluded that cornstarch
powder used as a donning agent on NRL gloves can increase sensitization
to NRL compared to exposure to NRL antigens alone.
    In 2002, Smither et al. (Ref. 41) presented a case report of a 58-
day-old male infant with bilateral scrotal masses due to a foreign body
reaction to glove powder following a pyloromyotomy performed shortly
after birth. In 2004, Sj[ouml]sten et al. (Ref. 40) extended their
prior work on the adverse effects of glove powder in animals to a
clinical observational study. They found that in patients who underwent
vaginal examination 1 or 4 days prior to a scheduled hysterectomy with
either powdered or non-powdered gloves, examination of the removed
tissues postoperatively detected more starch particles in the cervix
and uterus of patients examined with powdered gloves. There were no
differences between the patient groups in the numbers of starch
particles seen in the distant sites of the Fallopian tubes or the
peritoneal fluid. In 2 patients examined with powdered gloves, no
starch particles were found, and 3 patients examined with only powder-
free gloves had a few starch particles in their tissues.

    Odum et al. (Ref. 43) studied a guinea pig model of paravertebral
abscess formation. They reported that when slurries of either calcium
carbonate (CaCO3) or cornstarch were added to guinea pig
wounds along with Staphylococcus aureus, the wounds with added
CaCO3 had higher bacterial counts 4 days later than did the
wounds with added cornstarch, and both had higher bacterial counts than
the control wounds with only S. aureus inoculated. This study was
considered by the authors to support an increased risk of wound
infection after wound exposure to powdered gloves. In addition, Dave et
al. (Ref. 42) reviewed the literature on glove powder relating to
dental powdered glove use and noted that cornstarch promoted wound
infection in reported animal model studies and that cost-effective
powder-free gloves were available. The authors recommended the use of
non-powdered gloves in place of powdered gloves. Dwivedi et al. (Ref.
37) studied both NRL and synthetic latex gloves, both powdered and
unpowdered in a rat laparotomy model. They found that both non-powdered
natural rubber latex and powdered surgical gloves resulted in
peritoneal adhesions. However, powdered NRL gloves further promoted
increased tissue adhesions, which correlated with elevated serum
cytokine levels. They suggested that the use of NRL free, powder-free
gloves would be most effective in decreasing peritoneal adhesion
formation. In 2010, Suding et al. (Ref. 44) performed another study of
the effect of cornstarch on experimental model abscess formation. They
found that the injection of starch into wound sites increased the
likelihood of methicillin-resistant S. aureus injection abscess
formation in a rat model.

E. Actions of Other Regulatory Entities and Professional Organizations

    Over the past several years, some domestic health care
organizations, health care systems, and other nations have banned or
restricted the use of glove powder because of its deleterious effects
on the body. Organizations such as the National Institute for
Occupational Safety and Health (NIOSH), the American Academy of
Allergy, Asthma, and Immunology (ACAAI), the American College of
Surgeons (ACS), and the American Nurses Association have all issued
statements discouraging the use of powdered NRL gloves (Refs. 59 to
61). In June 1997, the NIOSH of the CDC issued an Alert titled
``Preventing Allergic Reactions to Natural Rubber Latex in the
Workplace'' (Ref. 59) in which it recommended that if NRL gloves are
used in the workplace, they should not be powdered. The ACS issued a
statement from their Committee on Perioperative Care in 1997 that
recommended that surgeons should insist on using only non-powdered
(``powder-free'') surgeons gloves (Ref. 62). The ACAAI issued a
recommendation (Ref. 60) on the use of NRL gloves in 1997 and stated
that only non-powdered (``powder-free'') NRL gloves should be purchased
and used in order to reduce NRL aeroallergen levels and exposure to
them.
    Moreover, health care systems including the Johns Hopkins Hospital,
the Cleveland Clinic's network of nine hospitals, and the University of
Virginia Healthcare System have all restricted or banned the use of
powdered NRL gloves in their facilities (Refs. 63-64). Finally, the
international health care systems of Germany and the United Kingdom
have also independently taken steps against the use of powdered NRL
gloves due to the dangers of the devices and the hazards they pose in
the health care setting (Refs. 65-66).
    The Occupational Safety and Health Administration (OSHA) of the
Department of Labor (DOL) issued a Technical Information Bulletin (TIB
99-04-12) in 1999 and updated it in 2008 (SHIB 01-28-2008) (Ref. 67)
describing the risk of sensitization to natural rubber latex products
used in the workplace. In both of its documents, OSHA recommended that,
if NRL gloves must be used, they should be non-powdered (``powder-
free'').
    In the 1998 CDC Guideline for Infection Control in Hospital
Personnel-1998 (Ref. 68), CDC addressed the issues of NRL sensitization
in the health care workplace and recommended that the use of non-
powdered natural rubber latex gloves would be more efficient than other
interventions such as trying to wash powder off gloves in reducing NRL
allergy in the workplace when NRL gloves were retained instead of
replaced.
    In January 2000, the New Jersey Department of Health and Senior
Services (DHSS) issued ``Guidelines on the Management of Natural Rubber
Latex Allergy; Selecting the Right Glove for the Right Task'' (Ref. 69)
for the health care facility environment. The New Jersey DHSS
recommended that reduced powder or, preferably, non-powdered NRL gloves
be used when NRL gloves are selected.
    Allmers and colleagues (Ref. 25) reported that a revised version of
the technical regulations for dangerous substances (TRGS 540) was
published in Germany in December 1997 that stated that the use of
powdered natural rubber latex gloves was not permissible in the
workplace; only ``powder-free'' NRL gloves could be used.
    In the United Kingdom in 2008, the National Health Service (NHS)
Plus Occupational Health Clinical Effectiveness Unit, in association
with the Royal College of Surgeons, issued evidence-based guidelines
(Ref. 70) on ``the occupational aspects of latex allergy management.''
These guidelines include the recommendation that when NHS employers
determine that a NRL glove is the most suitable choice for use against
a specific hazard, the NRL glove selected should be a low NRL protein
glove without glove powder.
    In 2011, the Association of Professionals in Infection Control and
Epidemiology (APIC) responded to the FDA's request for comments on
information related to risks and benefits of powdered gloves (Docket
No. FDA-2011-N-0027). APIC stated (Ref. 71) that it supported the use
of powder-free surgeon's gloves in health care. It stated also that it
agreed with the position of the ACS and that of the Association of
Perioperative Registered Nurses (AORN) that powdered gloves increase
the risk of sensitization to NRL antigens. APIC also noted that the
evidence for the role of glove powder in surgical site infection risk
is limited.

F. Analysis of Medical Device Adverse Events Reported to FDA for
Medical Gloves

    On its own initiative, FDA evaluated adverse event reports for
medical gloves that use powder as additional information to help
determine whether the standard for initiating a ban was met and, if so,
whether a ban was the appropriate regulatory action to address the
unreasonable and substantial risk of illness or injury presented by
powdered gloves.
    We performed a search of our Manufacturer and User Facility Device
Experience (MAUDE) database to isolate reports through September 30,
2015, to evaluate the number of adverse events reported for all types
of medical gloves. A total of 3,780 reports were identified, including
some that identify inflammation and granulomas. The reports retrieved
in this query date back to 1992. Charting the reports entered by year
indicates a bell curve in which the majority of reports were entered in
1999 with 783 reports. Since 1999, the number of adverse events
reported for these devices has consistently decreased, and since 2003,
the number of adverse events reported for these devices has tapered off
to consistently remain below 100 per year. FDA believes that this
reduction can be

attributed to the risks of powdered gloves becoming better known, which
has led to suitable powder-free alternatives being developed and
becoming more widely available on the market.
    As discussed in section VIII ``Economic Analysis of Impacts,''
market analysis clearly indicates that use of powdered gloves is
declining, but some individuals and organizations continue to use them
despite the risks of illness or injury they present. As such, health
care workers, patients, and other individuals who come in contact with
glove powder are being exposed to risks unnecessarily, which is one of
the reasons that FDA decided to initiate this ban.
[GRAPHIC] [TIFF OMITTED] TP22MR16.001

III. The Reasons FDA Initiated the Proceeding; Determination That
Powdered Gloves Present an Unreasonable and Substantial Risk of Illness

    As described in section 1.D, section 516(a)(1) of the FD&C Act
authorizes FDA to ban a device intended for human use by regulation if
it finds, on the basis of all available data and information, that such
a device ``presents substantial deception or an unreasonable and
substantial risk of illness or injury'' In this section, we describe
the reasons we initiated the proceeding to ban powdered gloves,
including the determination that powdered gloves present an
unreasonable and substantial risk of illness or injury. In order to
make this determination, we analyzed both the benefits and the risks
that these devices pose to those that may come into contact with them,
comparing those benefits and risks to the benefits and risks posed by
similar alternative devices.
    As explained in section II, the level and types of risk presented
by powdered gloves varies depending on the composition and intended use
of the glove. While some glove types present less risk than others, we
have concluded that the public's exposure to such risk is substantial
in relation to the nominal public health benefit derived from the
continued marketing of these devices. Further, it is FDA's position
that exposure to these risks is unreasonable in the current market
where suitable alternatives are readily available that carry none of
the risks presented by powdered gloves.
    The risk of acute severe airway inflammation due to ADP inhalation
is a risk presented by all powdered glove types and absorbable powder
alone and is considered important, material, and significant in
relation to the minimal potential benefits of greater ease of donning
and doffing and decreased tackiness. In considering these risks
relative to the state of the art and alternative non-powdered gloves
that do not present risks of acute severe airway inflammation, FDA has
determined that these risks are substantial and unreasonable.
    The risks of inflammatory responses, hypersensitivity reactions,
and allergic reactions, including asthma, allergic rhinitis,
conjunctivitis, and dyspnea, are risks presented by all powdered latex
glove types. FDA has determined that these risks are important,
material, and significant risks in relation to the minimal potential
benefits of greater ease of donning and doffing and decreased
tackiness. In relation to the state of the art of alternative non-
powdered gloves that do not present risks of inflammatory responses,
hypersensitivity reactions, and allergic reactions, we conclude that
these risks are substantial and unreasonable.
    The risk of granuloma and adhesion formation is presented to
patients and health care workers via exposure to internal tissue
through the use of powdered latex or synthetic surgeon's and patient
examination gloves. FDA has determined that this risk is important,
material, and significant in relation to the minimal potential benefits
of greater ease of donning and doffing and decreased tackiness. In
relation to the state of the art of

alternative non-powdered gloves that do not present risk of granuloma
and adhesion formation, we have concluded that this risk is substantial
and unreasonable.
    A critical aspect of these devices that FDA considered in coming to
the decision to propose this ban is their ability to affect persons
other than the individual who decides to wear or use them. Patients
often do not know the type of gloves being worn by the health care
professional treating them, but are still exposed to the potential
dangers of those gloves. Glove powder's expansive danger zone includes
persons, including other health care workers, completely unaware or
unassociated with its employment. In addition, users wear gloves as a
conventional prophylactic measure to prevent harm, but may be exposed
to the myriad harms posed by powdered gloves. Although we have noticed
a progressive reduction in the market share of powdered gloves, some
individuals and institutions continue to use them. This, in turn, has
led to continued exposure to the risks presented by powdered gloves.
    In aggregate, the risks posed by these devices include severe
airway inflammation, hypersensitivity reactions, allergic reactions
(including asthma), allergic rhinitis, conjunctivitis, dyspnea, as well
as granuloma and adhesion formation when exposed to internal tissue.
The state of the art of both surgeon's and patient examination gloves
includes non-powdered alternatives that provide similar performance as
the various powdered glove types do: That is, there are many non-
powdered gloves available that have the same level of protection,
dexterity, and performance. The benefits of these devices appear to
only include ease of donning and doffing and increased tackiness. We
have concluded that these benefits are nominal, and that the risks that
are posed by the continued marketing of powdered gloves outweigh those
benefits in all instances, especially in light of the current state of
the art, and the fact that readily available alternatives exist in
today's market that carry none of these risks. As such, FDA has
determined that the standard to ban powdered gloves has been met, and
that it is appropriate to issue this proposal to ban.

IV. FDA's Determination That Labeling, or a Change in Labeling, Cannot
Correct or Eliminate the Risk

    FDA has determined that powdered surgeon's gloves, powdered patient
examination gloves, and absorbable powder for lubricating a surgeon's
glove present an unreasonable and substantial risk of illness or injury
to individuals, and that no change in labeling could correct the risk
of illness or injury presented by the continued use of these devices.
FDA has determined that a ban is the appropriate regulatory approach to
addressing risks posed by glove powder. No labeling or warnings can
mitigate the risks posed by these devices.
    As discussed previously, powdered gloves have additional or
increased risks to health compared to non-powdered gloves related to
the spread of powder and powder-transported contaminants such as latex
allergens through aerosols and inhalation or direct or indirect contact
with wounds, oral, vaginal, rectal tissue, etc. Although labeling can
raise awareness of these risks, we do not conclude that labeling can
effectively mitigate these risks because it cannot prohibit the spread
of glove powder or powder-transported contaminants. In addition, an
important aspect of these devices is their ability to affect persons
other than the individual who decides to wear or use them. For example,
patients often do not know the type of gloves being worn by the health
care professional treating them, but are still exposed to the potential
dangers. Similarly, glove powder's ability to aerosolize and carry NRL
proteins exposes individuals to harm via inhalation or surface contact.
Glove powder's expansive danger zone includes persons completely
unaware or unassociated with its employment and without the opportunity
to consider the devices' labeling. Because of this inherent quality,
adequate directions for use cannot be written that would ensure the
safe and effective use of these devices for all persons that might come
in contact with them.
    In the now withdrawn draft guidance entitled ``Draft Guidance for
Industry and FDA Staff: Recommended Warning for Surgeon's Gloves and
Patient Examination Gloves that Use Powder,'' FDA proposed a general
voluntary warning for powdered glove devices in order to alert users to
the potential adverse health effects of medical glove powder while FDA
assessed the benefits and risks of glove powder (Ref. 7) (80 FR 26059).
In order to facilitate this assessment, concurrent with the issue of
this draft guidance document, we issued a notice in the Federal
Register requesting public input on the benefits and risks of powdered
gloves (76 FR 6684, February 7, 2011; FDA-2011-N-0027). Many of the
comments we received, in addition to a citizen petition filed in 2011
(FDA-2011-P-0331-0001), indicated that labeling would not sufficiently
address the risks posed by glove powder because a warning label would
not be visible to everyone affected by risks of glove powder.
    Although the use of powdered gloves has declined in recent years,
the use of these devices has not been eliminated, and patients and
health care workers continue to be exposed to the risks of glove
powder. Due to the ability of powder to affect people who would not
have an opportunity to read warning labels, such a label would be
ineffective at informing the affected persons of potential risks. In
addition, potential warning labels would raise awareness of the risks,
but would not eliminate the risks posed by glove powder. Therefore,
despite declining use of powdered gloves and previous warning label
suggestions, FDA has determined no label or warning can mitigate the
risks posed by these devices.
    Due to the nature of the risks presented by glove powder that are
posed simply by virtue of the powder being used, we do not conclude
that additional or new labeling can adequately correct or eliminate the
risks. As such, in light of all available data and information, FDA has
determined that it should address the risks posed by glove powder by
banning its use.

V. FDA's Determination That the Ban Applies to Devices Already in
Commercial Distribution and Sold to Ultimate Users, and the Reasons for
This Determination

    FDA has determined that this ban, if finalized, should apply to
devices already in commercial distribution and devices already sold to
the ultimate user, as well as to devices that would be sold or
distributed in the future. (See 21 CFR 895.21(d)(7).) This means that
powdered gloves currently being used in the marketplace would be
subject to this ban, and thus adulterated under section 501(g) of the
FD&C Act and would be subject to enforcement action.
    FDA made this determination because the risks of illness or injury
to individuals who are currently exposed to these devices is equally
unreasonable and substantial as it would be for future individuals that
might be exposed to powdered gloves. Indeed, because suitable
alternatives already exist in the current marketplace, and because the
market trends have shown that powder glove use is steadily decreasing,
it is likely that the remaining users of powder gloves will be able to
quickly transition to alternatives that are equally effective and carry
none of the risks associated with powdered gloves. Further, because of
the steady decrease

in powdered glove use, it is likely that the greatest number of people
that might benefit from the ban include those who would be exposed to
powdered gloves already in distribution. It is our conclusion that this
group is being unnecessarily exposed to risks that can be eliminated
through the use of alternative gloves that are readily available. For
these reasons, FDA has determined that the ban should apply to powdered
gloves and glove powder already in commercial distribution.

VI. Legal Authority

    This proposed rule, if finalized, would amend Sec. Sec.  878.4460,
878.4480, 880.6250, 895.102, 895.103, and 895.104. FDA's legal
authority to modify Sec. Sec.  878.4460, 878.4480, 880.6250, 895.102,
895.103, and 895.104 arises from the device and general administrative
provisions of the FD&C Act (21 U.S.C. 352, 360f, 360h, 360i, and 371).

VII. Environmental Impact

    FDA has carefully considered the potential environmental effects of
this proposed rule and of possible alternative actions. In doing so, we
focused on the environmental impacts of its action as a result of
disposal of unused powdered surgeon's gloves, powdered patient
examination gloves, and absorbable powder for lubricating a surgeon's
glove that will need to be handled after the rule is finalized.
    The environmental assessment (EA) considered each of the
alternatives in terms of the need to provide maximum reasonable
protection of human health without resulting in a significant impact on
the environment. The EA considered environmental impacts related to
landfill and incineration of solid waste. The proposed action, if
finalized, will result in an initial batch disposal of unused powdered
surgeon's gloves, powdered patient examination gloves, and absorbable
powder for lubricating a surgeon's glove at user facilities nationwide,
followed by a rapid decrease in the rate of disposal of these devices,
as supplies are depleted. The proposed action does not change the
ultimate disposition of these devices but expedites their rate of
disposal and ceases future production. Overall, given the limited
number of powdered surgeon's gloves, powdered patient examination
gloves, and absorbable powder for lubricating a surgeon's glove,
currently in commercial distribution, the proposed action is expected
to have no significant impact on landfill and solid waste facilities
and the environment in affected communities.
    The Agency has concluded that the proposed rule will not have a
significant impact on the human environment, and that an environmental
impact statement is not required. FDA's finding of no significant
impact (FONSI) and the evidence supporting that finding, contained in
an EA prepared under 21 CFR 25.40, may be seen in the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday (Ref. 72). FDA invites comments and submission of data
concerning the EA and FONSI.

VIII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the proposed rule. We believe that this
proposed rule is not a significant regulatory action as defined by
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this rule imposes no new burdens, we propose to
certify that the final rule would not have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2014) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.

B. Summary

    The proposed rule, if finalized, would prohibit marketing of
powdered surgeon's gloves, powdered patient examination gloves, and
absorbable powder for lubricating surgeon's gloves. The rule does not
cover or include powdered radiographic gloves. In the past, powdering
gloves was a popular method to make the gloves easier to put on and
remove. However, recent studies indicate that these powders pose an
unnecessary risk to medical workers (Ref. 73 and 74). Their results
note that these powders carry the latex material on latex gloves. As a
result, medical workers who are sensitive to latex are occasionally
exposed to enough latex to develop an allergy.
    Adopting the proposed rule is expected to provide a positive net
benefit (estimated benefits minus estimated costs) to society. Banning
powdered glove products is not expected to impose any costs to society
because improvements to non-powdered gloves have made these products as
affordable and easy to put on as powdered gloves. The ban is expected
to reduce the adverse events associated with using powdered gloves.
Total annual benefits are estimated to range between $26.6 million and
$29.3 million.
    The Economic Analysis of Impacts of the proposed rule performed in
accordance with Executive Order 12866, Executive Order 13563, the
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act is
available at http://www.regulations.gov under the docket number(s)
(FDA-2015-N-5017) for this proposed rule and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref.
75). We invite comments on this analysis.

IX. Proposed Effective Date

    FDA is proposing that any final rule based on this proposed rule
become effective 30 days after the date of its publication in the
Federal Register. FDA proposes that manufacturers must not market any
new units of affected devices after the effective date of any final
rule based on this proposal. FDA requests comment on the proposed
effective date for this proposed rule. Once this rule is finalized, all
powdered surgeon's gloves, powdered patient examination gloves, and
absorbable powder for lubricating a surgeon's gloves must be removed
from the market by the effective date provided in the final rule or the
device will be deemed adulterated. Section 501(g) of the FD&C

Act deems a device to be adulterated if it is a banned device.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

XI. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe . . . a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Federal law includes an express preemption
provision that preempts certain State requirements ``different from or
in addition to'' certain Federal requirements applicable to devices (21
U.S.C. 360k; See Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); Riegel
v. Medtronic, Inc., 552 U.S. 312 (2008)). This proposed rule, if
finalized, would create a requirement under 21 U.S.C. 360k that bans
Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and
Absorbable Powder for Lubricating a Surgeon's Glove.

XII. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. ``Guidance for Industry and FDA Staff: Medical Glove Guidance
Manual,'' January 22, 2008, available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM428191.pdf.
2. Association for Testing and Materials, ``ASTM D6124 Standard Test
Method for Residual Powder on Medical Gloves,'' 2011, available at:
http://www.astm.org/Standards/D6124.htm.
3. Ellis, H., ``The Hazards of Surgical Glove Dusting Powders,''
Surgery, Gynecology and Obstetrics, 171(6):521-527, 1990.
4. Ellis, H., ``Pathological Changes Produced by Surgical Dusting
Powders,'' Annals of the Royal College of Surgeons of England,
76(1):5-8, 1994, available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2502175/.
5. Food and Drug Administration, Stratmeyer, M., T. Cunningham, A.
Lowery, et al., Medical Glove Powder Report. 1997, available at:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm113316.htm.
6. ``Draft Guidance for Industry and FDA: Medical Glove Guidance
Manual,'' issued July 30, 1999; withdrawn January 22, 2008.
7. ``Draft Guidance for Industry and FDA Staff: Recommended Warning
for Surgeon's Gloves and Patient Examination Gloves that Use
Powder,'' issued February 7, 2011; withdrawn April 27, 2015.
8. Ahmed, S.M., T.C. Aw, and A. Adisesh, ``Toxicological and
Immunological Aspects of Occupational Latex Allergy,'' Toxicological
Reviews, 23(2):123-134, 2004.
9. Fisher, M.D., V.R. Reddy, F.M. Williams, et al., ``Biomechanical
Performance of Powder-Free Examination Gloves,'' The Journal of
Emergency Medicine, 17(6):1011-1018, 1999, available at: http://www.sciencedirect.com/science/article/pii/S073646799900133X.
10. Kerr, L.N., M.P. Chaput, L.D. Cash, et al., ``Assessment of the
Durability of Medical Examination Gloves,'' Journal of Occupational
and Environmental Hygiene, 1(9):607-612, 2004.
11. Korniewicz, D.M., M. El-Masri, J.M. Broyles, et al.,
``Performance of Latex and Nonlatex Medical Examination Gloves
During Simulated Use,'' American Journal of Infection Control,
30(2):133-138, 2002, available at: http://www.sciencedirect.com/science/article/pii/S0196655302751626.
12. Patel, H.B., G.J. Fleming, and F.J. Burke, ``Puncture Resistance
and Stiffness of Nitrile and Latex Dental Examination Gloves,''
British Dental Journal, 196(11):695-700, available at: http://www.nature.com/bdj/journal/v196/n11/full/4811353a.html.
13. Rego, A. and L. Roley, ``In-Use Barrier Integrity of Gloves:
Latex and Nitrile Superior to Vinyl,'' American Journal of Infection
Control, 27(5):405-410, 1999, available at: http://www.sciencedirect.com/science/article/pii/S0196655399700064.
14. Sawyer, J. and A. Bennett, ``Comparing the Level of Dexterity
Offered by Latex and Nitrile SafeSkin Gloves,'' The Annals of
Occupational Hygiene, 50(3):289-296, 2006, available at: http://annhyg.oxfordjournals.org/content/50/3/289.long.
15. Truscott, W., ``Glove Powder Reduction and Alternative
Approaches,'' Methods, 27(1):69-76, 2002, available at: http://www.sciencedirect.com/science/article/pii/S1046202302000543.
16. Truscott, W., ``The Industry Perspective on Latex,'' Immunology
and Allergy Clinics of North America, 15(1):89-121, 1995.
17. Cooke, S.A. and D.G. Hamilton, ``The Significance of Starch
Powder Contamination in the Aetiology of Peritoneal Adhesions,''
British Journal of Surgery, 64(6):410-412, 1977.
18. Luijendijk, R.W., D.C. de Lange, C.C. Wauters, et al., ``Foreign
Material in Postoperative Adhesions,'' Annals of Surgery,
223(3):242-248, 1996, available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1235111/.
19. McEntee, G.P., R.C. Stuart, P.J. Byrne, et al., ``Experimental
Study of Starch-Induced Intraperitoneal Adhesions,'' British Journal
of Surgery, 77(10):1113-1114, 1990.
20. Charous, B.L., P.J. Schuenemann, and M.C. Swanson, ``Passive
Dispersion of Latex Aeroallergen in a Healthcare Facility,'' Annals
of Allergy, Asthma & Immunology, 85(4):285-290, 2000, available at:
http://www.sciencedirect.com/science/article/pii/S1081120610625318.
21. Edelstam, G., L. Arvanius, and G. Karlsson, ``Glove Powder in
the Hospital Environment--Consequences for Healthcare Workers,''
International Archives of Occupational and Environmental Health,
75(4):267-271, 2002, availabe at: http://link.springer.com/article/10.1007%2Fs00420-001-0296-y.
22. Kujala, V., H. Alenius, T. Palosuo, et al., ``Extractable Latex
Allergens in Airborne Glove Powder and in Cut Glove Pieces,''
Clinical & Experimental Allergy, 32(7):1077-1081, 2002, available
at: http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2222.2002.01413.x/full.
23. Saary, M.J., A. Kanani, H. Alghadeer, et al., ``Changes in Rates
of Natural Rubber Latex Sensitivity Among Dental School Students and
Staff Members After Changes in Latex Gloves,'' Journal of Allergy
and Clinical Immunology, 109(1):131-135, 2002, available at: http://www.sciencedirect.com/science/article/pii/S0091674902343148.
24. Barbara, J., M.C. Santais, D.A. Levy, et al., ``Immunoadjuvant
Properties of Glove Cornstarch Powder in Latex-Induced
Hypersensitivity,'' Clinical and Experimental Allergy, 33(1):106-
112, 2003, available at: http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2222.2003.01573.x/full.
25. Allmers, H., R. Brehler, Z. Chen, et al., ``Reduction of Latex
Aeroallergens and Latex-Specific IgE Antibodies in Sensitized
Workers After Removal of Powdered Natural Rubber Latex Gloves in a
Hospital,'' Journal of Allergy and Clinical Immunology, 102(5):841-
846, 1998.
26. Allmers, H., J. Schmengler, and S.M. John, ``Decreasing
Incidence of Occupational Contact Urticaria Caused by Natural Rubber
Latex Allergy in German Health Care Workers,'' Journal of Allergy
and Clinical Immunology, 114(2):347-351, 2004, available at: http://www.sciencedirect.com/science/article/pii/S0091674904015684.
27. Allmers, H., J. Schmengler, and C. Skudlik, ``Primary Prevention
of Natural

Rubber Latex Allergy in the German Health Care System Through
Education and Intervention,'' Journal of Allergy and Clinical
Immunology, 110(2):318-323, 2002, available at: http://www.sciencedirect.com/science/article/pii/S0091674902000970.
28. Charous, B.L., C. Blanco, S. Tarlo, et al., ``Natural Rubber
Latex Allergy After 12 Years: Recommendations and Perspectives,''
Journal of Allergy and Clinical Immunology, 109(1):31-34, 2002.
29. Cuming, R.G., ``Reducing the Hazards of Exposure to Cornstarch
Glove Powder,'' AORN Journal, 76(2):288-295, 2002.
30. Filon, F.L. and G. Radman, ``Latex Allergy: A Follow Up Study of
1040 Healthcare Workers,'' Journal of Occupational and Environmental
Medicine, 63(2):121-125, 2006, available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2078060/.
31. Jackson, E.M., J.A. Arnette, M.L. Martin, et al., ``A Global
Inventory of Hospitals Using Powder-Free Gloves: A Search for
Principled Medical Leadership,'' Journal of Emergency Medicine,
18(2):241-246, 2000, available at: http://www.sciencedirect.com/science/article/pii/S0736467999002024.
32. Korniewicz, D.M., N. Chookaew, J. Brown, et al., ``Impact of
Converting to Powder-Free Gloves. Decreasing the Symptoms of Latex
Exposure in Operating Room Personnel,'' American Association of
Occupational Health Nurses Journal, 53(3):111-116, 2005.
33. Liss, G.M. and S.M. Tarlo, ``Natural Rubber Latex-Related
Occupational Asthma: Association With Interventions and Glove
Changes Over Time,'' American Journal of Industrial Medicine,
40(4):347-353, 2001.
34. Malerich, P.G., M.L. Wilson, and C.M. Mowad, ``The Effect of a
Transition to Powder-Free Latex Gloves on Workers' Compensation
Claims for Latex-Related Illness,'' Dermatitis, 19(6):316-318, 2008.
35. Vandenplas, O., A. Larbanois, F. Vanassche, et al., ``Latex-
Induced Occupational Asthma: Time Trend in Incidence and
Relationship With Hospital Glove Policies,'' Allergy, 64(3):415-420,
2009.
36. Chegini, N. and H. Rong, ``Postoperative Exposure to Glove
Powders Modulates Production of Peritoneal Eicosanoids During
Peritoneal Wound Healing,'' European Journal of Surgery, 165(7):698-
704, 1999.
37. Dwivedi, A.J., N.K. Kuwajerwala, Y.J. Silva, et al., ``Effects
of Surgical Gloves on Postoperative Peritoneal Adhesions and
Cytokine Expression in a Rat Model,'' American Journal of Surgery,
188(5):491-494, 2004, available at: http://www.sciencedirect.com/science/article/pii/S0002961004003526.
38. Sj[ouml]sten, A.C., H. Ellis, and G.A. Edelstam, ``Post-
Operative Consequences of Glove Powder Used Pre-Operatively in the
Vagina in the Rabbit Model,'' Human Reproduction, 15(7):1573-1577,
2000, available at: http://humrep.oxfordjournals.org/content/15/7/1573.long.
39. van den Tol, M.P., R. Haverlag, M.E. van Rossen, et al., ``Glove
Powder Promotes Adhesion Formation and Facilitates Tumour Cell
Adhesion and Growth,'' British Journal of Surgery, 88(9):1258-1263,
2001.
40. Sj[ouml]sten, A.C., H. Ellis, and G.A. Edelstam, ``Retrograde
Migration of Glove Powder in the Human Female Genital Tract,'' Human
Reproduction, 19(4):991-995, 2004, available at: http://humrep.oxfordjournals.org/content/19/4/991.long.
41. Smither, A.R., A.L. Winthrop, and H.G. Mesrobian, ``Bilateral
Scrotal Masses in an Infant: Remote Presentation of an Inflammatory
Reaction to Surgical Glove Powder,'' The Journal of Urology,
168(6):2592-2593, 2002, available at: http://www.sciencedirect.com/science/article/pii/S0022534705642243.
42. Dave, J., M.H. Wilcox, and M. Kellett, ``Glove Powder:
Implications for Infection Control,'' Journal of Hospital Infection,
42(4):283-285, 1999, available at: http://www.sciencedirect.com/science/article/pii/S0195670198905928.
43. Odum, B.C., J.S. O'Keefe, W. Lara, et al., ``Influence of
Absorbable Dusting Powders on Wound Infection,'' Journal of
Emergency Medicine, 16(6):875-879, 1998, available at: http://www.sciencedirect.com/science/article/pii/S0736467998001024?np=y.
44. Suding, P., T. Nguyen, I. Gordon, et al., ``Glove Powder
Increases Staphylococcus Aureus Abscess Rate in a Rat Model,''
Surgical Infections, 11(2):133-135, 2010.
45. Aarons, J. and N. Fitzgerald, ``The Persisting Hazards of
Surgical Glove Powder,'' Surgery, Gynecology, and Obstetrics,
138(3):385-390, 1974.
46. Hamlin, C.R., A.L. Black, and J.T. Opalek, ``Assay Interference
Caused by Powder From Prepowdered Latex Gloves,'' Clinical
Chemistry, 37(8):1460, 1991.
47. Sharefkin, J.B., K.D. Fairchild, R.A. Albus, et al., ``The
Cytotoxic Effect of Surgical Glove Powder Particles on Adult Human
Vascular Endothelial Cell Cultures: Implications for Clinical Uses
of Tissue Culture Techniques,'' Journal of Surgical Research,
41(5):463-472, 1986.
48. Liakakos, T., N. Thomakos, P.M. Fine, et al., ``Peritoneal
Adhesions: Etiology, Pathophysiology, and Clinical Significance.
Recent Advances in Prevention and Management,'' Digestive Surgery,
18(4):260-273, 2001.
49. Mahadevan, M. M., D. Wiseman, A. Leader, et al., ``The Effects
of Ovarian Adhesive Disease Upon Follicular Development in Cycles of
Controlled Stimulation for In Vitro Fertilization,'' Fertility and
Sterility, 44(4):489-492, 1985.
50. Mecke, H., K. Semm, I. Freys, et al., ``Incidence of Adhesions
in the True Pelvis After Pelviscopic Operative Treatment of Tubal
Pregnancy,'' Gynecologic and Obstetric Investigation, 28(4):202-204,
1989.
51. Ylikorkala, O., ``Tubal Ligation Reduces the Risk of Ovarian
Cancer,'' Acta Obstetricia et Gynecologica Scandinavica, 80(10):875-
877, 2001, available at: http://onlinelibrary.wiley.com/doi/10.1034/j.1600-0412.2001.801001.x/pdf.
52. Global Industry Analysts, Inc., ``Disposable Medical Gloves: A
Global Strategic Business Report,'' 2008.
53. Cote, S.J., M.D. Fisher, J.N. Kheir, et al., ``Ease of Donning
Commercially Available Latex Examination Gloves,'' Journal of
Biomedical Materials Research, 43(3):331-337, 1998, available at:
http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-
4636(199823)43:3%3C331::AID-JBM15%3E3.0.CO;2-I/pdf.
54. Gnaneswaran, V., B. Mudhunuri,, and R.R. Bishu, ``A Study of
Latex and Vinyl Gloves: Performance Versus Allergy Protection
Properties,'' International Journal of Industrial Ergonomics,
38:171-181, 2008.
55. Tarlo, S.M., A. Easty, K. Eubanks, et al., ``Outcomes of a
Natural Rubber Latex Control Program in an Ontario Teaching
Hospital,'' Journal of Allergy and Clinical Immunology, 108(4):628-
633, 2001, available at: http://www.sciencedirect.com/science/article/pii/S0091674901609850.
56. Handfield-Jones, S.E., ``Latex Allergy in Health-Care Workers in
an English District General Hospital,'' British Journal of
Dermatology, 138(2):273-276, 1998, available at: http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2133.1998.02073.x/pdf.
57. Sellar, P.W. and R.A. Sparrow, ``Are Ophthalmic Surgeons Aware
That Starch Powdered Surgical Gloves Are a Risk Factor in Ocular
Surgery?'' International Ophthalmology, 22:247-251, 1999.
58. Petsonk, E.L., ``Couriers of Asthma: Antigenic Proteins in
Natural Rubber Latex,'' Occupational Medicine: State of the Art
Reviews, 15(2):421-430, 2000.
59. CDC, ``Preventing Allergic Reactions to Natural Rubber Latex in
the Workplace,'' NIOSH Alert, pp. 97-135, 1997, available at: http://www.cdc.gov/niosh/docs/97-135/.
60. American College of Allergy, Asthma and Immunology, ``AAAAI and
ACAAI Joint Statement Concerning the Use of Powdered and Non-
Powdered Natural Rubber Latex Gloves,'' Annals of Allergy Asthma and
Immunology, 79:487, 1997.
61. American Nurses Association, ``American Nurses Association: Fact
Sheet,'' May 2011.
62. Meyer, K.K. and D.H. Beezhold, ``Latex Allergy: How Safe Are
Your Gloves?'' Bulletin of the American College of Surgeons,
82(7):13-15, 72, 1997.
63. Edlich, R.F., W.B. Long, D.K. Gubler, et al., ``Dangers of
Cornstarch Powder on Medical Gloves: Seeking a Solution,'' Annals of
Plastic Surgery, 63(1):111-115, 2009.
64. Edlich, R.F., C.R. Woodard, S.A. Pine, et al., ``Hazards of
Powder on Surgical and Examination Gloves: A Collective Review,''
Journal of Long-Term Effects of Medical Implants, 11(1-2):15-27,
2001.
65. Medical Devices Agency, ``Medical Devices Agency Safety Notice
9825:

Latex Medical Gloves (Surgeons' and Examination) Powdered Latex
Medical Gloves (Surgeons' and Examination),'' 1998, MDA: London.
66. Latza, U., F. Haamann, and X. Baur, ``Effectiveness of a
Nationwide Interdisciplinary Preventive Programme for Latex
Allergy,'' International Archives of Occupational and Environmental
Health, 78(5):394-402, 2005, available at: http://link.springer.com/article/10.1007%2Fs00420-004-0594-2.
67. U.S. Department of Labor, OSHA, Potential for Sensitization and
Possible Allergic Reaction To Natural Rubber Latex Gloves and Other
Natural Rubber Products, 2008. Available at: https://www.osha.gov/dts/shib/shib012808.html.
68. Bolyard, E.A., O.C. Tablan, W.W. Williams, et al., ``Guideline
for Infection Control in Healthcare Personnel, 1998. Hospital
Infection Control Practices Advisory Committee,'' Infection Control
and Hospital Epidemiology, 19(6):407-463, 1998.
69. Blumenstock, J.S., E. Bresnitz, and K. O'Leary, Guidelines
Management of Natural Rubber Latex Allergy; Selecting the Right
Glove for the Right Task in Healthcare Facilities, New Jersey
Department of Health and Senior Services, ed. B. Gerwel, 2000.
70. United Kingdom National Health Service, N.P., Royal College of
Physicians, Faculty of Occupational Medicine, ``Latex Allergy:
Occupational Aspects of Management. A National Guideline,'' 2008,
London: RCP.
71. Olmsted, R., ``APIC response to FDA Docket # FDA-2011-N-0027,''
available at www.regulations.gov, 2011.
72. ``Finding of No Significant Impact (FONSI) and Environmental
Analysis for Banned Devices; Proposal to Ban Powdered Surgeon's
Gloves, Powdered Patient Examination Gloves, and Absorbable Powder
for Lubricating a Surgeon's Glove.''
73. Korniewicz, D.M., N. Chookaew, M. El-Masri, et al., ``Conversion
to Low-Protein, Powder-Free Surgical Gloves: Is It Worth the Cost?''
American Association of Occupational Health Nurses Journal,
53(9):388-393, 2005.
74. Ranta, P.M. and D.R. Ownby, ``A Review of Natural-Rubber Latex
Allergy in Health Care Workers,'' Clinical Infectious Diseases,
38(2):252-256, 2004.
75. ``Preliminary Regulatory Impact Analysis, Initial Regulatory
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for
Banned Devices; Proposal to Ban Powdered Surgeon's Gloves, Powdered
Patient Examination Gloves, and Absorbable Powder for Lubricating a
Surgeon's Glove,'' available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Parts 878 and 880

    Medical devices.

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 878, 880, and 895 be amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Amend Sec.  878.4460 by revising the heading and paragraph (a) to
read as follows:

Sec.  878.4460  Non-powdered surgeon's glove.

    (a) Identification. A non-powdered surgeon's glove is a device made
of natural rubber latex or synthetic latex, intended to be worn by
operating room personnel to protect a surgical wound from
contamination. A non-powdered surgeon's glove does not incorporate
powder for purposes other than manufacturing. The final finished glove
includes only residual powder from manufacturing.
* * * * *

Sec.  878.4480  [Removed]

0
3. Remove Sec.  878.4480.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
4. The authority citation for 21 CFR part 880 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
5. Amend Sec.  880.6250 by revising the heading and paragraph (a) to
read as follows:

Sec.  880.6250  Non-powdered patient examination glove.

    (a) Identification. A non-powdered patient examination glove is a
disposable device made of either natural rubber latex or synthetic
latex, intended for medical purposes, that is worn on the examiner's
hand or finger to prevent contamination between patient and examiner. A
non-powdered patient examination glove does not incorporate powder for
purposes other than manufacturing. The final finished glove includes
only residual powder from manufacturing.
* * * * *

PART 895--BANNED DEVICES

0
6. The authority citation for 21 CFR part 895 continues to read as
follows:

    Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371.

0
7. Add Sec.  895.102 to subpart B to read as follows:

Sec.  895.102  Powdered surgeon's glove.

    A powdered surgeon's glove is a device made of natural rubber latex
or synthetic latex, intended to be worn by operating room personnel to
protect a surgical wound from contamination. A powdered surgeon's glove
incorporates powder for purposes other than manufacturing.
0
8. Add Sec.  895.103 to subpart B to read as follows:

Sec.  895.103  Powdered patient examination glove.

    A powdered patient examination glove is a disposable device made of
natural rubber latex or synthetic latex, intended for medical purposes,
that is worn on the examiner's hand or finger to prevent contamination
between patient and examiner. A powdered patient examination glove
incorporates powder for purposes other than manufacturing.
0
9. Add Sec.  895.104 to subpart B to read as follows:

Sec.  895.104  Absorbable powder for lubricating a surgeon's glove.

    Absorbable powder for lubricating a surgeon's glove is a powder
made from cornstarch that meets the specifications for absorbable
powder in the United States Pharmacopeia (U.S.P.) and that is intended
to be used to lubricate the surgeon's hand before putting on a
surgeon's glove. The device is absorbable through biological
degradation.

    Dated: March 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-06360 Filed 3-21-16; 8:45 am]
BILLING CODE 4164-01-P