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
K200453Substantially Equivalent

Non-Sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs Blue-Ac

Yty Industry (Manjung) Sdn. Bhd., Sitiawan, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K200453 is the FDA 510(k) clearance record for NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC, a class I device, cleared for Yty Industry (Manjung) 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 27 510(k) clearances for Yty Industry (Manjung) Sdn Bhd, from to . As of , FDA records show no recalls naming K200453.

Clearance record

Decision date
Received
(67 days to decision)
Product code
LZA Polymer Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Yty Industry (Manjung) Sdn Bhd Lot 1422-1424, Sitiawan, MY
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