Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)

Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) is an FDA 510(k)-cleared medical device (K161195) manufactured by M3 Global Enterprises, 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 August 24, 2016. Regulation: 8.