SURGICAL FACE MASK (Ear Loops and Tie-on)

SURGICAL FACE MASK (Ear Loops and Tie-on) is an FDA 510(k)-cleared medical device (K133070) manufactured by Bh Medical Products Co., Ltd.. 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 June 21, 2015. Regulation: 8.