DEFEND Ear-loop Face Masks

DEFEND Ear-loop Face Masks is an FDA 510(k)-cleared medical device (K201127) manufactured by Young Dental Manufacturing Co. 1, 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 April 13, 2021. Regulation: 8.