ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM

ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM is an FDA 510(k)-cleared medical device (K082529) manufactured by Alatech Healthcare, LLC. 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 April 30, 2009. Regulation: 8.