Sempermed Derma Plus, Sizes 5.5,6,6.5,7,7.5,8,8.5,9

K012819 is the FDA 510(k) clearance record for SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9, a class I device, cleared for Semperit Technische Produkte Gesellshaft on 2001-11-16 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 3 510(k) clearances for Semperit Technische Produkte Gesellshaft, from 1998-10-29 to 2002-01-16. As of 2026-09-10, FDA records show no recalls naming K012819.