LOVE GUARD MALE LATEX CONDOM

LOVE GUARD MALE LATEX CONDOM is an FDA 510(k)-cleared medical device (K080833) manufactured by Tianjin Human-Care Latex Corporation. 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 6, 2008. Regulation: 8.