
Guey Her Ent. Co. , Ltd.
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SURGEON'S GLOVES is an FDA 510(k)-cleared medical device (K895823) manufactured by Guey Her Ent. Co. , Ltd.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 23, 1990. Regulation: 8.