Synthetic Polyisoprene Lubricated Male Condom - 5 senses

Synthetic Polyisoprene Lubricated Male Condom - 5 senses is an FDA 510(k)-cleared medical device (K182438) manufactured by Sxwell USA, 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 December 5, 2018. Regulation: 8.