OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM

OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM is an FDA 510(k)-cleared medical device (K012402) manufactured by Omnigrace (Thailand) , Ltd.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 11, 2001. Regulation: 8.