
Standard Textile Co., Inc.
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COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS is an FDA 510(k)-cleared medical device (K041653) 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 30, 2005. Regulation: 8.