LZCClass I

Medical Glove, Specialty

21 CFR 880.6250 / General Hospital

LZC is the FDA product code for Medical Glove, Specialty, a class I device type, regulated under 21 CFR 880.6250. FDA's definition for this code reads: "A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc". As of 2026-09-10, FDA records hold 79 510(k) clearances under this code, the most recent dated 2026-01-14, and 8 recalls.

Classification record

Product code: LZC
Device name: Medical Glove, Specialty
FDA definition: A disposable medical glove (examination or surgeon’s) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.
Regulation: 21 CFR 880.6250
Device class: Class I
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 79
Ingested recalls: 8

Clearances, product code LZC

By decision year

79 clearances under product code LZC with a decision year between 1989 and 2026, 2019 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code LZC by decision year
Year	Clearances
1989	3
1990	6
1991	2
1993	1
1994	2
1997	1
1998	1
1999	2
2001	1
2003	2
2004	2
2007	1
2008	3
2009	5
2010	5
2012	4
2015	1
2016	3
2017	6
2018	6
2019	7
2020	3
2021	3
2022	7
2025	1
2026	1

Applicants with the most clearances

Product code LZC

Applicants holding the most 510(k) clearances under product code LZC
Applicant	Clearances
WRP Asia Pacific Sdn Bhd	5
Central Medicare Sdn Bhd	4
Cardinalhealth	3
Perusahaan Getah Asas Sdn. Bhd.	3
Shen Wei (USA), Inc.	3
Acufex Microsurgical, Inc.	2
GMP Medicare Sdn Bhd(F25)	2
Guardian Group, Inc.	2
Halyard Health	2
JR Engineering and Medical Technologies (M) Sdn Bhd	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 259 companies shown, in name order