[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Pages 6685-6686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2543]
[[Page 6685]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0030]
Draft Guidance for Industry and Food and Drug Administration
Staff; Recommended Warning for Surgeon's Gloves and Patient Examination
Gloves That Use Powder; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Recommended Warning for
Surgeon's Gloves and Patient Examination Gloves that Use Powder.'' This
draft guidance document provides a recommended warning statement
related to medical gloves that contain powder or use donning or dusting
powder, specifically surgeon's gloves and patient examination gloves
(medical gloves that use powder). FDA is concerned about the potential
adverse health effects from the use of powder on medical gloves and is
recommending that the labeling for powdered medical gloves provide a
warning related to the potential health effects. This draft guidance is
not final nor is it in effect at this time. Elsewhere in this issue of
the Federal Register, FDA is announcing the establishment of a public
docket to receive comments related to surgeon's gloves and patient
examination gloves that contain or use donning or dusting powder.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 9, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Recommended Warning for Surgeon's Gloves
and Patient Examination Gloves That Use Powder'' to the Division of
Small Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993. Send
one self-addressed adhesive label to assist that office in processing
your request, or fax your request to 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Subhas Malghan, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 62, rm. 3204, Silver Spring, MD 20993-0002, 301-796-2548,
[email protected]; or Sheila Murphey, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 2510, Silver Spring, MD 20993-0002, 301-796-6302,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Medical gloves are a significant factor in the protection of both
patients and health care personnel in the United States. Health care
personnel rely on medical gloves as a barrier against transmission of
infectious diseases and contaminants when conducting surgery as well as
in more limited interactions with patients.
Following the recognition of acquired immunodeficiency syndrome
(AIDS) as a major public health concern and recommendations from the
Centers for Disease Control and Prevention that health care workers use
appropriate barrier precautions to prevent exposure to the human
immunodeficiency virus (HIV), FDA recognized the need for greater
assurance that cross-contamination between patients and health care
workers be prevented. 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
assure 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 (55 FR 51254), FDA published regulations
describing certain circumstances under which surgeon's and patient
examination gloves would be considered adulterated. The regulations
established the sampling plans and test methods for glove leakage
defects that the Agency would use to determine whether gloves were
adulterated. (See 21 CFR 800.20). Subsequently, FDA initiated
inspections of glove manufacturers to assure conformance with the
acceptable quality levels identified in the regulation.
In 1997, FDA issued the ``Medical Glove Powder Report'' discussing
the potential adverse health effects of medical glove powder, along
with alternatives and current market information available at that
time. Adverse health events reviewed by the Medical Glove Powder Report
included: (1) Aerosolized powder on natural rubber latex (NRL) gloves
carrying allergenic proteins as a cause of respiratory allergic
reactions; (2) rhinitis, conjunctivitis, and dyspnea; (3) respiratory
problems; (4) granuloma formation; and (5) peritoneal adhesions.
FDA is issuing this draft guidance with a recommended warning
statement for powdered medical gloves. The statement should inform
users of the potential adverse health effects from these devices,
including foreign body reaction, formation of granulomas, and
peritoneal adhesion especially with multiple surgeries. The warning
should also include information on increases in respiratory ailments,
and development of irritant dermatitis or Type IV allergy when glove
powder is used on NRL gloves. In addition, the warning should state
that powder used on NRL medical gloves can serve as a carrier for
airborne allergenic natural rubber latex proteins.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized will represent the Agency's current thinking on ``Recommended
Warning for Surgeon's Gloves and Patient Examination Gloves that Use
Powder.'' It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used, but should address the identified risks inherent to
powdered gloves.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Recommended Warning for Surgeon's Gloves and Patient Examination
Gloves that Use Powder,'' you may either send an e-mail request to
[email protected] to receive an electronic copy of the document or
send
[[Page 6686]]
a fax request to 301-847-8149 to receive a hard copy. Please use the
document number 1704 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 801 have been
approved under OMB control number 0910-0485. In addition, FDA concludes
that the labeling statement in section 4 of the guidance does not
constitute a ``collection of information'' under the PRA. Rather, this
labeling statement is ``public disclosure of information originally
supplied by the Federal government to the recipient for the purpose of
disclosure to the public.'' (5 CFR 1320.3(c)(2)).
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 1, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-2543 Filed 2-4-11; 8:45 am]
BILLING CODE 4160-01-P