[Federal Register Volume 64, Number 146 (Friday, July 30, 1999)]
[Notices]
[Pages 41744-41745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19192]
Federal Register / Vol. 64, No. 146 / Friday, July 30, 1999 /
Notices
[[Page 41744]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-2335]
Medical Gloves; Draft Guidance Manual; Availability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availability of the draft guidance entitled ``Medical Glove Guidance
Manual.'' The draft guidance represents a major revision of this
guidance document, which was initially issued in 1993 under the title
``Guidance for Medical Gloves: A Workshop Manual.'' This draft guidance
is intended to provide current information to assist manufacturers and
others in obtaining marketing clearance, applying manufacturing and
design controls, and properly labeling medical gloves. This draft
guidance also includes recommendations for limits on the amounts of
glove powder and natural latex protein present on surgeon's and patient
examination gloves. Elsewhere in this issue of the Federal Register,
the FDA is proposing reclassification of surgeon's gloves and patient
examination gloves into class II (special controls) because the agency
believes that special controls are necessary to provide reasonable
assurance of the safety and effectiveness of the gloves. The agency is
proposing that the draft guidance ``Medical Glove Guidance Manual'' be
one of the special controls, and the agency is requesting comment on
the content of the manual at this time.
DATES: Submit written comments concerning this draft guidance by
October 28, 1999 for consideration prior to implementation of the
guidance as a special control.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance. Submit written requests for single copies
on a 3.5'' diskette of the guidance document entitled ``Medical Glove
Guidance Manual'' to the Division of Small Manufacturers Assistance''
(HFZ-220), Center for Devices and Radiological, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-443-8818. Submit written comments
concerning this guidance to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Comments should be identified with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Arthur K. Yellin, Center for Devices
and Radiological Health (HFZ-200), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 800-638-2041, ext. 146, 301-443-6597,
ext. 146.
SUPPLEMENTARY INFORMATION:
I. Background
Medical gloves are a significant factor in the protection of both
patients and health care personnel in the United States. Because of the
increased reliance on medical gloves as a barrier against transmission
of infectious diseases and contaminants, it is imperative that they be
manufactured and labeled in accordance with FDA laws and regulations.
Originally entitled ``Guidance for Medical Gloves: A Workshop
Manual,'' this document was first published in May 1993 to assist
manufacturers in preparing premarket notification (510(k)) submissions
for medical gloves and applying quality systems requirements (formerly
known as good manufacturing practices, or GMP) to the production of
medical gloves. It has been used extensively as a text in training
workshops provided by the FDA to the regulated industry. It is heavily
relied upon and widely recognized as a valuable resource to those
currently in, or seeking to enter, the United States medical glove
market.
The draft guidance has been revised to address and emphasize the
agency's growing concerns about the role of glove powder as a cause of
foreign body reactions and as a carrier of airborne natural latex
allergens. The draft guidance recommends that manufacturers of powdered
surgeon's and patient examination gloves limit the amount of powder to
no more than 120 milligrams (mg) of powder per glove, regardless of
glove size. It further recommends that manufacturers of powder-free
surgeon's and patient examination gloves limit the amount of total
trace (residual) powder on gloves to no more than 2 mg particulate
weight (based on the American Society for Testing Materials Standard
Test Method for Residual Powder on Medical Gloves (D 6124-97)) per
glove, regardless of glove size.
The draft guidance also includes a recommendation that
manufacturers of natural rubber latex surgeon's and patient examination
gloves limit the amount of water-extractable protein on the gloves to
no more than 1200 micrograms of protein per glove, regardless of glove
size.
II. Significance of Guidance
This draft guidance represents the agency's current thinking on
medical gloves. 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 if such approach satisfies the applicable statute,
regulations, or both.
The agency has adopted good guidance practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This draft guidance document is issued as a Level 1 guidance
consistent with GGP's.
III. Electronic Access
Persons interested in obtaining a copy of the medical glove
guidance manual may do so using the World Wide Web (WWW). CDRH
maintains an entry on the WWW for access to information including text,
graphics, and files that may be downloaded to a personal computer with
access to the WWW. Updated on a regular basis, the CDRH home page
includes the medical glove guidance manual, device safety alerts,
access to Federal Register reprints, information on premarket
submissions including lists of approved applications and manufacturers'
addresses, small manufacturers' assistance, information on video
conferencing and electronic submissions, mammography matters, and other
device-oriented information. The CDRH home page may be accessed at
``http://www.fda.gov/cdrh''. The medical glove guidance manual is
available at``http://www.fda.gov/cdrh/manual/glovmanl.pdf''.
You may also receive instructions about obtaining the medical
glove guidance manual via your fax machine. To do so call the CDRH
Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a
touch-tone telephone. At the first voice prompt, press 1 to access DSMA
Facts, at the second voice prompt, press 2, and then enter the document
number (852) followed by the pound sign (#). Then follow the remaining
voice prompts to complete your request.
IV. Comments
Interested persons may, on or before October 28, 1999 submit to
Dockets Management Branch (address above) written comments regarding
this draft guidance. Two copies of any comments are to be submitted,
except that
[[Page 41745]]
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
draft guidance and received comments may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: July 15, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19192 Filed 7-29-99; 8:45 am]
BILLING CODE 4160-01-F
