
Thantex Specialties, Inc.
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ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS is an FDA 510(k)-cleared medical device (K942200) manufactured by Thantex Specialties, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 6, 1995. Regulation: 8.