For Consumers
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Barrier Products
Information about barrier products used to prevent the transmission of HIV.
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Condoms
Condoms: Barriers to Bad News
A primer about condom use to prevent disease transmissionCondoms and Sexually Transmitted Diseases, Brochure
(1990)Female Condom
approved. On May 7, 1993, FDA approved the Reality Female Condom which offers women a barrier product to protect themselves without relying on the cooperation of their partner. A new version, the FC2, was approved on March 9, 2009.Regulatory Requirements for Obtaining Marketing Clearance
in the United States for Barrier Devices Used During Oral Sex for STD Protection, October 31, 1996Latex Condoms for Men -- Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions (PDF - 89KB)
Center for Devices and Radiological Health (issued 7/23/98; posted 7/27/98)Uniform Contraceptive Labeling (PDF - 94KB)
Center for Devices and Radiological Health (issued 7/23/98; posted 7/27/98)Testing guidance for Male Condoms Made from New Material (Non-Latex) (Text Only)
Prepared by Center for Devices and Radiological Health, Office of Device Evaluation, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Obstetrics-Gynecology Devices Branch- Condoms and STDs: Fact Sheet (CDC)
Male Latex Condoms and Sexually Transmitted Diseases: CDC Fact Sheet
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Gloves
Medical Glove Guidance Manual
January 22, 2008Medical Glove Powder Report
September 1997FDA Public Health Advisory: Potential Risk of Spontaneous Combustion in Large Quantities of Patient Examination Gloves
June 27, 1996
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Microbicides: Chemical Barriers to HIV
This section includes examples of presentations from public meetings and literature publications in which FDA staff have participated. These provide illustrations of regulatory perspectives and issues relevant to microbicide development
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