BARRIER FABRIC 450 SURGICAL GOWNS

BARRIER FABRIC 450 SURGICAL GOWNS is an FDA 510(k)-cleared medical device (K760903) manufactured by Surgikos, Inc.. 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 10, 1976. Regulation: 8.