Non-spermicidal Lubricated Male Latex Condom

Non-spermicidal Lubricated Male Latex Condom is an FDA 510(k)-cleared medical device (K193578) manufactured by Global Protection Corp.. 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 19, 2020. Regulation: 8.