What is FDA product code KGO?

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 barrier against potentially infectious materials and other contaminants.

General & Plastic Surgery › SurgicalSurgeon'S Gloves

Sterile Nitrile Surgical Gloves, Size 6 1/2

Name: Sterile Nitrile Surgical Gloves, Size 6 1/2
Brand: Sterile Nitrile Surgical Gloves, Size 6 1/2

Catalogue number 6534, listed by Dynarex Corp., United States, under Surgeon'S Gloves. 10 manufacturers in China are registered for this product code.

Registry build 21.09.26

10manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (2), Shanghai (2), Guangxi (2).

Chinese manufacturers registered for FDA product code KGO
Manufacturer	City	Province	Registered as	Device types
Huzhou Junda Industry Co., Ltd.	Anji	Zhejiang	Contract manufacturer	129
Ningbo Risenmed Technology Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	42
Guangzhou Huada Biotechnology Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	9
Suzhou Colour-way New Material Co., Ltd.	Suzhou	Jiangsu	Manufacturer	5
Shanghai Motex Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	4
Motex Healthcare (Anhui) Co., Ltd.	Guangde City, Xuancheng	Anhui	Manufacturer	4
Shanghai Jinxiang Latex Products Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	3
Guilin HBM Health Protections, Inc.	Guilin	Guangxi	Manufacturer	2
Puyang Linshi Medical Supplies Co., Ltd.	Puyang	Henan	Contract manufacturer	2
Guilin Huada Biotechnology Co., Ltd.	Guilin	Guangxi	Contract manufacturer	1

Record

Regulatory record for Sterile Nitrile Surgical Gloves, Size 6 1/2
Listed by	Dynarex Corp., United States
FDA product code	KGO
Device type	Surgeon’S Gloves
Device class	Class 1
Regulation	21 CFR 878.4460
Establishment	Specification developer, Manufacturer
Record published	2022-04-22
Record revised	2026-05-18 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Box of 50, case of 4

Catalogue Numbers

Catalogue numbers for Sterile Nitrile Surgical Gloves, Size 6 1/2
Catalogue number	Size	Status
6534		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
MocareHealth	Motex Healthcare (Anhui) Co., Ltd.	398
Biogel	Bosma Enterprises	149
Protexis	Cardinal Health 200, LLC	141
Medline	Medline Industries, Inc.	130
Gammex	Ansell Healthcare Product	126
Medline Industries, Inc.	Medline Industries, Inc.	118
McKesson	Mckesson Medical-Surgical Inc.	112
Novaplus	Ansell Healthcare Product	85
PremierPro Surgeons Glove	Prestige Ameritech	78
Gammex	Bosma Enterprises	63
Protexis	Bosma Enterprises	63
Encore	Ansell Healthcare Product	60

Showing 12 of 106. All products under Surgeon’S Gloves

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.