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 Church & Dwight Co., Inc..
List of Condom devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Condom devices (product code HIS). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Obstetrics & Gynecology FDA review panel. Browse all Obstetrics & Gynecology devices →