Powdered Nitrile Medical Examination Glove, Colored

K983531 is the FDA 510(k) clearance record for POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED, a class I device, cleared for Shanghai Antares Industries, Inc. on 1998-11-30 under FDA product code LYZ (Vinyl Patient Examination Glove). FDA's definition for product code LYZ reads: "A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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 14 510(k) clearances for Shanghai Antares Industries, Inc., from 1998-09-30 to 2005-11-22. As of 2026-09-10, FDA records show no recalls naming K983531.