MALE LATEX CONDOM

MALE LATEX CONDOM is an FDA 510(k)-cleared medical device (K012653) manufactured by Qingdao Shuang Die Latex Production 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 September 20, 2001. Regulation: 8.