SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9)

SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9) is an FDA 510(k)-cleared medical device (K993782) manufactured by P.T. Vonix Latexindo Condom (Rubber) Mfg.. 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 February 1, 2000. Regulation: 8.