HIV and AIDS
Human Immunodeficiency
Virus and
Acquired Immunodeficiency Syndrome
Barrier Products
Condoms
- 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
Gloves
Latex Allergies
Other
- 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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