Halyard Black-Orange Powder-Free Nitrile Exam Glove

K153708 is the FDA 510(k) clearance record for Halyard Black-Orange Powder-Free Nitrile Exam Glove, a class I device, cleared for Halyard Health on 2016-03-31 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 96 510(k) clearances for Halyard Health, from 1978-02-23 to 2025-01-31. As of 2026-09-10, FDA records show no recalls naming K153708.