FDA Product Code HIS: Condom

Male condoms are among the most widely used contraceptive and STI prevention devices. FDA product code HIS covers condoms cleared as contraceptive devices.

These barrier devices are worn over the penis during sexual intercourse to prevent pregnancy and reduce the transmission of sexually transmitted infections including HIV, gonorrhea, and chlamydia. They are available in latex, polyurethane, and natural membrane formulations.

HIS devices are Class II medical devices, regulated under 21 CFR 884.5300 and reviewed by the FDA Obstetrics & Gynecology panel.

Leading manufacturers include Carter Products, Okamoto USA, Inc. and Mayer Laboratories.