Derma Prene Ultra Powder-Free Polychloroprene Synthetic Surgical Gloves (Chemotherapy Use)

K043508 is the FDA 510(k) clearance record for DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE), a class I device, cleared for Ansell Healthcare Products, LLC on 2005-01-19 under FDA product code KGO (Surgeon'S Gloves). FDA's definition for product code KGO reads: "A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a...". FDA records list 39 510(k) clearances for Ansell Healthcare Products, LLC, from 2000-07-31 to 2023-10-20. As of 2026-09-10, FDA records show no recalls naming K043508.