HI-TOUCH (TM) BRAND SURGICAL GLOVES

HI-TOUCH (TM) BRAND SURGICAL GLOVES is an FDA 510(k)-cleared medical device (K874539) manufactured by Apex Medical Technologies, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 13, 1987. Regulation: 8.