LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9

LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 is an FDA 510(k)-cleared medical device (K024324) manufactured by Global Protection Corp.. 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 March 24, 2003. Regulation: 8.