LYY · Latex Patient Examination Glove · Chrysalis Intelligence

Device class

Class I

Regulation 880.6250

Total clearances

2020-12-01 → 2025-04-29

Last 12 months

Unique sponsors

Definition

What is Latex Patient Examination Glove

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 details

Medical specialty

General Hospital

Review panel

Regulation number

880.6250

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Most recent
Sri Trang Gloves (Thailand) Public Company Limited	3	2024-09-09
Pt. Universal Gloves	2	2021-11-19
Shandong Intco Medical Products Co, Ltd.	2	2023-02-22
Amazing Rubber Products Pvt, Ltd.	1	2022-05-28
Iconic Medicare Sdn Bhd	1	2022-08-25
Hi-Care Thai Gloves Co. , Ltd.	1	2020-12-01
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.	1	2022-07-14
Avecena Gloves Sdn Bhd	1	2022-04-24
Careplus (M) Sdn Bhd	1	2021-08-20
Wrp Asia Pacific Sdn. Bhd.	1	2022-08-22
New Era Medicare Sdn. Bhd.	1	2022-10-28
Kossan International Sdn Bhd	1	2023-06-13
Thai Rubber Gloves Co., Ltd.	1	2021-12-29
Comfort Rubber Gloves Industries Sdn. Bhd.	1	2025-04-29
Jr Engineering & Medical Technologies (M) Sdn. Bhd.	1	2022-10-27
Guangdong Kingfa Sci. & Tech.Co., Ltd.	1	2022-11-25
Hebei Titans Hongsen Medical Technology Co., Ltd.	1	2022-10-26
Fitone Latex Products Co., Ltd. Guangdong	1	2022-09-24
Aspen Glove Sdn. Bhd.	1	2021-09-20
Thanh Cong Pharmaceutical and Trading Company Limited	1	2022-06-22
Shen Wei USA, Inc.	1	2021-08-19
Thai Rubber Industry Company Limited	1	2021-12-07
Bestsafe Glove Co., Ltd.	1	2021-11-05

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A4014	HCPCS	—	High	HCPCS code for latex examination gloves, per 100 gloves

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-04-29	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
2024-09-09	K240266	Sri Trang Gloves (Thailand) Public Company Limited	Latex Examination Glove Powder Free (Ocean Blue and Natural White)
2023-06-13	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)
2023-02-22	K223298	Shandong Intco Medical Products Co, Ltd.	Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
2022-11-25	K222612	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Powder-Free Latex examination gloves
2022-10-28	K221667	New Era Medicare Sdn. Bhd.	Non Sterile Powder Free Latex Examination Glove
2022-10-27	K222348	Jr Engineering & Medical Technologies (M) Sdn. Bhd.	JR MEDIC
2022-10-26	K221374	Hebei Titans Hongsen Medical Technology Co., Ltd.	Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
2022-09-24	K222693	Fitone Latex Products Co., Ltd. Guangdong	Single-use medical latex examination gloves (LG100)
2022-08-25	K221648	Iconic Medicare Sdn Bhd	Iconic Latex Glove
2022-08-22	K211601	Wrp Asia Pacific Sdn. Bhd.	Powder Free Latex Examination Glove, Non-Sterile
2022-08-09	K212482	Sri Trang Gloves (Thailand) Public Company Limited	Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
2022-07-14	K214017	Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.	Examination gloves-Type A(Latex gloves)
2022-06-22	K221185	Thanh Cong Pharmaceutical and Trading Company Limited	TC Gloves
2022-05-28	K212597	Amazing Rubber Products Pvt, Ltd.	Amazing+ Latex Examination Powder Free Gloves
2022-04-24	K213775	Avecena Gloves Sdn Bhd	Glovatex White Latex Gloves, Glovanil Blue Nitrile Gloves
2022-04-08	K213509	Shandong Intco Medical Products Co, Ltd.	Latex Examination Gloves, Powder Free
2022-04-08	K212309	Sri Trang Gloves (Thailand) Public Company Limited	Non-sterile, Powder-Free Latex Examination Glove
2021-12-29	K213073	Thai Rubber Gloves Co., Ltd.	Goody Gloves, Wincare, TBG Gloves
2021-12-07	K212438	Thai Rubber Industry Company Limited	Comfortpro
2021-11-19	K203074	Pt. Universal Gloves	Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
2021-11-05	K210253	Bestsafe Glove Co., Ltd.	Best Glove-Latex Powder Free Examination Glove
2021-09-20	K211477	Aspen Glove Sdn. Bhd.	Latex Examination Powder Free Gloves
2021-08-20	K203705	Careplus (M) Sdn Bhd	Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
2021-08-19	K211620	Shen Wei USA, Inc.	Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)