KWIKEZE MALE CONDOM APPLICATOR

KWIKEZE MALE CONDOM APPLICATOR is an FDA 510(k)-cleared medical device (K031007) manufactured by Condax, 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 November 13, 2003. Regulation: 8.