Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K090066Substantially Equivalent

Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling Claim of 50 Micrograms per Dm2 of Glove

Wear Safe (Malaysia) Sdn Bhd, Klang, Selangor Darul Ehsan, MY / Traditional, Substantially Equivalent

K090066 is the FDA 510(k) clearance record for POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE, a class I device, cleared for Wear Safe (Malaysia) Sdn. Bhd. on under FDA product code KGO (Surgeon'S Gloves). FDA's definition for product code KGO reads: "A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a...". FDA records list 14 510(k) clearances for Wear Safe (Malaysia) Sdn. Bhd., from to . As of , FDA records show no recalls naming K090066.

Clearance record

Decision date
Received
(126 days to decision)
Product code
KGO Surgeon'S Gloves
Regulation
21 CFR 878.4460
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Wear Safe (Malaysia) Sdn. Bhd. Lot Pt. 13726,Jalan Haji Salleh, Klang, Selangor Darul Ehsan, MY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGO

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