KGOClass I

Surgeon'S Gloves

21 CFR 878.4460 / General, Plastic Surgery

KGO is the FDA product code for Surgeon'S Gloves, a class I device type, regulated under 21 CFR 878.4460. FDA's definition for this code 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 barrier against potentially infectious materials and other contaminants". As of 2026-09-10, FDA records hold 560 510(k) clearances under this code, the most recent dated 2026-07-28, and 44 recalls.

Classification record

Product code: KGO
Device name: Surgeon'S Gloves
FDA definition: 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.
Regulation: 21 CFR 878.4460
Device class: Class I
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 560
Ingested recalls: 44

Clearances, product code KGO

By decision year

560 clearances under product code KGO with a decision year between 1976 and 2026, 1989 the highest year at 46.

Show the numbers

510(k) clearances under FDA product code KGO by decision year
Year	Clearances
1976	5
1977	2
1978	2
1979	1
1980	3
1981	3
1982	3
1983	3
1984	7
1985	1
1986	4
1987	2
1988	23
1989	46
1990	29
1991	20
1992	12
1993	9
1994	10
1995	28
1996	12
1997	16
1998	16
1999	34
2000	23
2001	21
2002	18
2003	16
2004	7
2005	17
2006	10
2007	10
2008	2
2009	3
2010	6
2011	11
2012	7
2013	6
2014	7
2015	12
2016	9
2017	12
2018	7
2019	11
2020	15
2021	14
2022	6
2023	14
2024	2
2025	1
2026	2

Applicants with the most clearances

Product code KGO

Applicants holding the most 510(k) clearances under product code KGO
Applicant	Clearances
Medtronic, Inc.	26
WRP Asia Pacific Sdn Bhd	20
Ansell Healthcare Products LLC	17
Molnlycke Health Care, US LLC	16
Ansell Perry	15
Terang Nusa (Malaysia) Sdn. Bhd.	15
Wembley Rubber Products (M) Sdn Bhd	15
MEDLINE INDUSTRIES, LP - Northfield	12
Johnson & Johnson MEDICAL GmbH	10
Maxxim Medical	10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 123 companies shown, in name order