Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves

K220825 is the FDA 510(k) clearance record for Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves, a class I device, cleared for American Nitrile Operations, LLC on 2022-07-08 under FDA product code LZA (Polymer Patient Examination Glove). FDA's definition for product code LZA reads: "A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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...". FDA records list one 510(k) clearance for American Nitrile Operations, LLC. As of 2026-09-10, FDA records show one recall naming K220825.