Durex Condom with Benzocaine

Durex Condom with Benzocaine is an FDA 510(k)-cleared medical device (K211152) manufactured by Rb Health (Us), LLC. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 10, 2022. Regulation: 8.