Powder-Free Nitrile, Poly-Coated Examination Glove, Purple or White (Non-Colored)

K972838 is the FDA 510(k) clearance record for POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED), a class I device, cleared for Absolute Synthetic Technologies Malaysia Sdn. Bhd. on 1997-08-15 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 3 510(k) clearances for Absolute Synthetic Technologies Malaysia Sdn. Bhd., from 1997-07-29 to 1997-08-15. As of 2026-09-10, FDA records show no recalls naming K972838.