HIV and AIDS
Human Immunodeficiency Virus and
Acquired Immunodeficiency Syndrome

Barrier Products

Condoms: Barriers to Bad News, by Tamar Nordenberg, FDA Consumer March/April 1998
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.
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, 89 KB], Center for Devices and Radiological Health (issued 7/23/98; posted 7/27/98)
Uniform Contraceptive Labeling [PDF, 32 KB], Center for Devices and Radiological Health (issued 7/23/98; posted 7/27/98)
Information for Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch, FDA. This Draft document outlines the information which should be included for a premarket notification (510(k)) submission for a natural latex rubber condom.
Testing Guidance for Male Condoms Made From New Material, 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

Guidance for Medical Gloves, A Workshop Manual Prepared by the Office of Health and Industry Programs, Division of Small Manufacturers Assistance, CDRH, September 1997
Medical Glove Powder Report, September 1997
FDA Public Health Advisory: Potential Risk of Spontaneous Combustion in Large Quantities of Patient Examination Gloves, June 27, 1996

On January 8, 1998, FDA approved Glyde Dam Lollyes (Glyde USA, Inc., Redmond, WA 98052-4712) designed as a barrier for use while performing cunnilingus. When properly used, it may help reduce the risk of catching or spreading many Sexually Transmitted Diseases (STDs) such as syphilis, gonorrhea, chlamydia infections, genital herpes and HIV; however, it cannot eliminate the risk.
On February 19, 1999, FDA approved Sheer Glyde Dams (Glyde USA, Inc., Redmond, WA 98052-4712) designed as a barrier for use while performing cunnilingus (oral/vaginal sex) or anilingus (oral/anal sex [rimming]). When properly used, it may help reduce the risk of catching or spreading many Sexually Transmitted Diseases (STDs) such as syphilis, gonorrhea, chlamydia infections, genital herpes and HIV; however, they cannot eliminate the risk. Do not use during penetrating penile/vaginal or penile/anal intercourse.

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