Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs

K201748 is the FDA 510(k) clearance record for Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs, a class I device, cleared for Hartalega Sdn Bhd on 2020-10-02 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 61 510(k) clearances for Hartalega Sdn Bhd, from 1989-05-31 to 2020-10-02. As of 2026-09-10, FDA records show no recalls naming K201748.