FDA product code LYY: Latex Patient Examination Glove

LYY is the FDA product code for latex patient examination glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel. FDA has cleared 1,954 510(k) submissions under LYY, 18 in the last five years, from 1,104 different applicants. The average 510(k) review took 104 days (median 79); 166 days on average over the last three years. FDA has posted 6 recalls for LYY devices.

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.

Classification

Field	Value
Device name	Latex Patient Examination Glove
Device class	Class I
Regulation	21 CFR 880.6250
Review panel	HO — General Hospital
Medical specialty	General Hospital
Premarket route	510(k)
Third-party 510(k) review eligible	Yes

510(k) clearances per year for LYY

Year	Clearances	Avg. review days
2017	4	213
2018	2	256
2019	1	90
2020	1	103
2021	8	214
2022	14	179
2023	2	111
2024	1	222
2025	1	109

Compare with all 510(k) review times · Search every LYY clearance

Top LYY applicants

Applicant	Clearances	Latest
Wembley Rubber Products (M) Sdn Bhd	37	1999-01-27
Sgmp Co., Ltd.	25	2012-09-12
Hartalega Sdn Bhd	19	2016-08-04
Siam Sempermed Corp., Ltd.	19	2010-07-09
Perusahaan Getah Asas Sdn. Bhd.	16	2003-06-26

1,099 more applicants have LYY clearances. See the full list in Caduvo.

Most recent LYY clearances

510(k)	Applicant	Device	Decision date	Review days
K250069	Comfort Rubber Gloves Industries Sdn. Bhd.	Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein	2025-04-29	109
K240266	Sri Trang Gloves (Thailand) Public Company Limited	Latex Examination Glove Powder Free (Ocean Blue and Natural White)	2024-09-09	222
K230573	Kossan International Sdn Bhd	Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)	2023-06-13	104
K223298	Shandong Intco Medical Products Co, Ltd.	Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)	2023-02-22	118
K222612	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Powder-Free Latex examination gloves	2022-11-25	87

Recalls for LYY devices

6 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-19.

Year	Recalls
2020	1

Frequently asked questions

What is FDA product code LYY?

LYY is the FDA product code for latex patient examination glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel.

What device class is LYY?

Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k).

How long does a 510(k) take for product code LYY?

Across 1,954 cleared submissions the average was 104 days from receipt to decision (median 79).

Which companies have the most LYY clearances?

Wembley Rubber Products (M) Sdn Bhd (37); Sgmp Co., Ltd. (25); Hartalega Sdn Bhd (19); Siam Sempermed Corp., Ltd. (19); Perusahaan Getah Asas Sdn. Bhd. (16).

Have LYY devices been recalled?

Yes: 6 product recalls across 5 recall events; the most recent began 2020-08-19.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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