INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED

INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED is an FDA 510(k)-cleared medical device (K041837) manufactured by Innolatex Sdn. 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 September 23, 2004. Regulation: 8.