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Guidance Issuing OfficeCenter for Devices and Radiological Health
Health care providers, professionals, and others use surgeons’ and/or patient examination gloves (subsequently referred to as “medical gloves” in this document) as a barrier against the transmission of blood- and fluid-borne pathogens. Because medical glove defects, such as holes, can compromise the effectiveness of the glove barrier and pose a potentially significant hazard to the health of users and their patients, FDA samples medicals gloves and performs water leak testing as described in Title 21, Code of Federal Regulation (CFR), Part 800.20.
FDA’s Center for Devices and Radiological Health (CDRH) is aware from its import records that some foreign manufacturers and shippers repeatedly attempt to import medical gloves that fail water leak testing (i.e., they do not meet the acceptable quality criteria defined in 21 CFR § 800.20, based on the number of defective medical gloves in the samples). To address the issue, FDA proposed a strategy for import surveillance and detention in the draft guidance made available on July 26, 2000. FDA is making available this final guidance document to provide guidance to FDA staff and industry, regarding FDA’s strategy for addressing further imports of medical gloves from manufacturers/shippers whose medical gloves have failed to meet FDA’s minimum acceptable quality criteria.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2000-D-0186.