Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K083409Substantially Equivalent

Powder Free Blue Latex Patient Examination Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label

WRP Asia Pacific Sdn Bhd, Salak Tinggi, Sepang Selangor, MY / Traditional, Substantially Equivalent

K083409 is the FDA 510(k) clearance record for POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL, a class I device, cleared for Wrp Asia Pacific Sdn. Bhd. on under FDA product code LZC (Medical Glove, Specialty). FDA's definition for product code LZC reads: "A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition...". FDA records list 46 510(k) clearances for Wrp Asia Pacific Sdn. Bhd., from to . As of , FDA records show no recalls naming K083409.

Clearance record

Decision date
Received
(253 days to decision)
Product code
LZC Medical Glove, Specialty
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Wrp Asia Pacific Sdn. Bhd. Lot 1, Jalan 3,, Salak Tinggi, Sepang Selangor, MY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZC

Trailing 12 months
1 clearance under product code LZC in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LZC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260