POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE

POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE is an FDA 510(k)-cleared medical device (K081040) manufactured by Pt.Shamrock Manufacturing Corp.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 19, 2008. Regulation: 8.