Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K892108Substantially Equivalent

Sterile Natural Latex Surgical Gloves

Ruhn Chang Industrial Co., Ltd., New City NY / Traditional, Substantially Equivalent

K892108 is the FDA 510(k) clearance record for STERILE NATURAL LATEX SURGICAL GLOVES, a class I device, cleared for Ruhn Chang Industrial Co., Ltd. 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 2 510(k) clearances for Ruhn Chang Industrial Co., Ltd., from to . As of , FDA records show no recalls naming K892108.

Clearance record

Decision date
Received
(158 days to decision)
Product code
KGO Surgeon'S Gloves
Regulation
21 CFR 878.4460
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Ruhn Chang Industrial Co., Ltd. 14 Delta Dr., New City NY
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