THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM

THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM is an FDA 510(k)-cleared medical device (K032909) manufactured by Thai Nippon Rubber Industry Co., Ltd.. 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 December 15, 2003. Regulation: 8.