THEYFIT MALE CONDOM

THEYFIT MALE CONDOM is an FDA 510(k)-cleared medical device (K122219) manufactured by Theyfit. 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 September 26, 2013. Regulation: 8.