Pre-Powdered Sterile Surgeon's Gloves (with a 50 Microgram/gm Protein Claim

K021065 is the FDA 510(k) clearance record for PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM, a class I device, cleared for Primus Gloves Private , Ltd. on 2002-05-08 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 4 510(k) clearances for Primus Gloves Private , Ltd., from 2002-02-26 to 2003-06-05. As of 2026-09-10, FDA records show no recalls naming K021065.