RICHTER MALE LATEX CONDOM

RICHTER MALE LATEX CONDOM is an FDA 510(k)-cleared medical device (K070511) manufactured by Richter Rubber Technology Sbn Bhd. 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 January 13, 2008. Regulation: 8.