ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES

ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES is an FDA 510(k)-cleared medical device (K033777) manufactured by Syntex Healthcare Products Co., Ltd.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 4, 2004. Regulation: 8.