LYYClass I

Latex Patient Examination Glove

21 CFR 880.6250 / General Hospital

LYY is the FDA product code for Latex Patient Examination Glove, a class I device type, regulated under 21 CFR 880.6250. FDA's definition for this code reads: "A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants". As of 2026-09-10, FDA records hold 1,954 510(k) clearances under this code, the most recent dated 2025-04-29, and 6 recalls.

Classification record

Product code: LYY
Device name: Latex Patient Examination Glove
FDA definition: A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
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: 1,954
Ingested recalls: 6

Clearances, product code LYY

By decision year

1,954 clearances under product code LYY with a decision year between 1988 and 2025, 1989 the highest year at 816.

Show the numbers

510(k) clearances under FDA product code LYY by decision year
Year	Clearances
1988	1
1989	816
1990	134
1991	47
1992	39
1993	54
1994	90
1995	72
1996	47
1997	50
1998	71
1999	110
2000	91
2001	64
2002	67
2003	37
2004	14
2005	18
2006	15
2007	12
2008	13
2009	7
2010	13
2011	11
2012	11
2013	6
2014	3
2015	3
2016	4
2017	4
2018	2
2019	1
2020	1
2021	8
2022	14
2023	2
2024	1
2025	1

Applicants with the most clearances

Product code LYY

Applicants holding the most 510(k) clearances under product code LYY
Applicant	Clearances
Wembley Rubber Products (M) Sdn Bhd	37
Sgmp Co., Ltd.	24
Hartalega Sdn Bhd	19
Siam Sempermed Corp., Ltd.	19
Perusahaan Getah Asas Sdn. Bhd.	16
Pamitex Industries Sdn Bhd	15
Shield Gloves Manufacturer (M) Sdn Bhd	15
Aladan Corp.	14
Shen Wei (USA), Inc.	14
Sri Johani Sdn. Bhd.	14

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 146 companies shown, in name order