510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K003922Substantially Equivalent

Nitrile Examination Gloves (Powered)

Guthrie Medicare Products (Melaka) Sdn Bhd, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003922 is the FDA 510(k) clearance record for NITRILE EXAMINATION GLOVES (POWERED), a class I device, cleared for Guthrie Medicare Products (Melaka) 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 12 510(k) clearances for Guthrie Medicare Products (Melaka) Sdn Bhd, from to . As of , FDA records show no recalls naming K003922.

Clearance record

Decision date
Received
(57 days to decision)
Product code
LZA Polymer Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Guthrie Medicare Products (Melaka) Sdn Bhd 55 Northern Blvd., Suite 200, Great Neck NY
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