TROJAN SIS Synthetic Latex Condom with Silicone Lubricant

TROJAN SIS Synthetic Latex Condom with Silicone Lubricant is an FDA 510(k)-cleared medical device (K240379) manufactured by Church & Dwight Co., Inc.. 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 October 7, 2024. Regulation: 8.