'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 is an FDA 510(k)-cleared medical device (K001978) 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 August 7, 2000. Regulation: 8.