Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)

K230573 is the FDA 510(k) clearance record for Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein), a class I device, cleared for Kossan International Sdn Bhd on 2023-06-13 under FDA product code LYY (Latex Patient Examination Glove). FDA's definition for product code LYY reads: "A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against...". FDA records list 12 510(k) clearances for Kossan International Sdn Bhd, from 2015-02-12 to 2026-01-13. As of 2026-09-10, FDA records show no recalls naming K230573.