LATEX PROPHYLACTIC (CONDOM)

LATEX PROPHYLACTIC (CONDOM) is an FDA 510(k)-cleared medical device (K912405) manufactured by Hevealactics Intl. Sdn Bhd. 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 20, 1992. Regulation: 8.