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
K101828Substantially Equivalent

Powder Free Latex Examination Gloves (18 Ml), Blue Tested for Use with Chemotherapy Drugs

Gx Corporation Sdn Bhd, Klang, Selangor, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K101828 is the FDA 510(k) clearance record for POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS, a class I device, cleared for Gx Corporation Sdn Bhd on under FDA product code LYY (Latex Patient Examination Glove). FDA's definition for product code LYY reads: "A latex patient examination glove is a disposable device made of natural rubber latex 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 provide a barrier against...". FDA records list 18 510(k) clearances for Gx Corporation Sdn Bhd, from to . As of , FDA records show no recalls naming K101828.

Clearance record

Decision date
Received
(95 days to decision)
Product code
LYY Latex Patient Examination Glove
Regulation
21 CFR 880.6250
Device class
Class I
Review panel
General Hospital
Applicant
Gx Corporation Sdn Bhd Lot 6487, Batu 5 3/4, Klang, Selangor, MY
510(k) summary
Statement
Third party review
No

Clearances, product code LYY

Trailing 12 months

FDA records hold no clearances under product code LYY in the trailing twelve months.

FDA records show no clearances under product code LYY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260