
Standard Textile Co., Inc.
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COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) is an FDA 510(k)-cleared medical device (K010799) 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 June 6, 2001. Regulation: 8.