PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501

PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 is an FDA 510(k)-cleared medical device (K091097) manufactured by Promedical 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 May 26, 2009. Regulation: 8.