
Ansell Healthcare Products, LLC
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Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs is an FDA 510(k)-cleared medical device (K182948) 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 March 21, 2019. Regulation: 8.