Skyn Original Polyisoprene Lubricated Male Condom

Skyn Original Polyisoprene Lubricated Male Condom is an FDA 510(k)-cleared medical device (K160399) manufactured by Ansell Healthcare Products, 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 July 24, 2016. Regulation: 8.