Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K032549Substantially Equivalent

Matang Powder-Free Polychloroprene Patient Examination Gloves

Matang Mfg. Sdn. Bhd., Alexandria VA / Traditional, Substantially Equivalent

K032549 is the FDA 510(k) clearance record for MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES, a class I device, cleared for Matang Mfg. Sdn. Bhd. on 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 8 510(k) clearances for Matang Mfg. Sdn. Bhd., from to . As of , FDA records show no recalls naming K032549.

Clearance record

Decision date
Received
(21 days to decision)
Product code
LZA Polymer Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Matang Mfg. Sdn. Bhd. 6324 Meetinghouse Way, Alexandria VA
510(k) summary
Statement
Third party review
No

Clearances, product code LZA

Trailing 12 months
15 clearances under product code LZA in the twelve months to October 2026, June 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code LZA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20265
July 20262
August 20261
September 20264
October 20260