Sterile Powdered Latex Surgeon Gloves

K010198 is the FDA 510(k) clearance record for STERILE POWDERED LATEX SURGEON GLOVES, a class I device, cleared for Supermax Glove Manufacturing Sdn Bhd on 2001-02-23 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 6 510(k) clearances for Supermax Glove Manufacturing Sdn Bhd, from 2000-03-17 to 2003-01-10. As of 2026-09-10, FDA records show no recalls naming K010198.