Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is an FDA 510(k)-cleared medical device (K153409) manufactured by Protect U Guard, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 2016. Regulation: 8.