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

K214074 is the FDA 510(k) clearance record for Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs, a class I device, cleared for Hartalega NGC Sdn. Bhd. on 2022-05-26 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 31 510(k) clearances for Hartalega NGC Sdn. Bhd., from 2014-06-20 to 2026-07-28. As of 2026-09-10, FDA records show no recalls naming K214074.