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For Consumers
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Barrier Products
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Condoms
- Condoms: Barriers to Bad News
A primer about condom use to prevent disease transmission - Condoms 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, 1996 - Latex 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
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Gloves
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