Lifestyles Zero Lubricated Latex Male Condom

Lifestyles Zero Lubricated Latex Male Condom is an FDA 510(k)-cleared medical device (K163107) manufactured by Ansell Healthcare Products, 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 January 22, 2017. Regulation: 8.