
Standard Textile Co., Inc.
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COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS is an FDA 510(k)-cleared medical device (K041540) manufactured by Standard Textile Co., 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 May 4, 2005. Regulation: 8.