Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K890459Substantially Equivalent

James River Biogel Powderless Surgical Gloves

James River Corp., Neenah WI / Traditional, Substantially Equivalent

K890459 is the FDA 510(k) clearance record for JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES, a class I device, cleared for James River Corp. 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 15 510(k) clearances for James River Corp., from to . As of , FDA records show no recalls naming K890459.

Clearance record

Decision date
Received
(80 days to decision)
Product code
KGO Surgeon'S Gloves
Regulation
21 CFR 878.4460
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
James River Corp. 1915 Marathon Ave., Neenah WI
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