Powder Free Synthetic Examination Gloves

K971356 is the FDA 510(k) clearance record for POWDER FREE SYNTHETIC EXAMINATION GLOVES, a class I device, cleared for Arista Latindo Industrial Ltd. P.T on 1997-09-05 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 21 510(k) clearances for Arista Latindo Industrial Ltd. P.T, from 1989-04-26 to 2004-07-15. As of 2026-09-10, FDA records show no recalls naming K971356.