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Ansell Healthcare Products, LLC
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DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) is an FDA 510(k)-cleared medical device (K043508) 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 January 18, 2005. Regulation: 8.