Gammex PI Breach Detect Powder Free Surgical Glove

Gammex PI Breach Detect Powder Free Surgical Glove is an FDA 510(k)-cleared medical device (K171375) manufactured by Ansell Healthcare Products, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 5, 2018. Regulation: 8.