DICK'S FORMALWEAR MALE LATEX CONDOM

DICK'S FORMALWEAR MALE LATEX CONDOM is an FDA 510(k)-cleared medical device (K050913) manufactured by Dick'S Formalwear, Inc.. 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 April 3, 2006. Regulation: 8.