HYCARE LATEX EXAMINATION GLOVE, POWDERED

HYCARE LATEX EXAMINATION GLOVE, POWDERED is an FDA 510(k)-cleared medical device (K010875) manufactured by Hycare Intl. Co., Ltd.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 6, 2001. Regulation: 8.