Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K001049Substantially Equivalent

Guthrie Powder-Free Latex Surgical Glove with (50 Micrograms or Less)

Guthrie Medicare Products (Melaka) Sdn Bhd, Great Neck NY / Traditional, Substantially Equivalent

K001049 is the FDA 510(k) clearance record for GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS), a class I device, cleared for Guthrie Medicare Products (Melaka) 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 12 510(k) clearances for Guthrie Medicare Products (Melaka) Sdn Bhd, from to . As of , FDA records show no recalls naming K001049.

Clearance record

Decision date
Received
(53 days to decision)
Product code
KGO Surgeon'S Gloves
Regulation
21 CFR 878.4460
Device class
Class I
Review panel
General, Plastic Surgery
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 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