LIFESTYLES ZERO LUBRICATED LATEX CONDOM

LIFESTYLES ZERO LUBRICATED LATEX CONDOM is an FDA 510(k)-cleared medical device (K120394) manufactured by Ansell Heathcare 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 May 7, 2012. Regulation: 8.