LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT

LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT is an FDA 510(k)-cleared medical device (K122477) 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 February 18, 2013. Regulation: 8.