LYZ · Vinyl Patient Examination Glove · Chrysalis Intelligence

Device class

Class I

Regulation 880.6250

Total clearances

2020-01-21 → 2026-04-07

Last 12 months

Unique sponsors

Definition

What is Vinyl Patient Examination Glove

A vinyl patient examination glove is a disposable device made of poly(vinyl chloride) 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	Last 12 mo	Most recent
Dezhou Hengchang Medical Technology Co., Ltd.	3	0	2022-08-25
Basic Medical Technology, Inc.	2	1	2026-04-07
Ever Global (Vietnam) Enterprise Corporation	2	0	2023-02-06
Anhui Bytech Medical Supplies Co., Ltd.	2	0	2022-09-28
Shandong Shengshixincheng Medical Science & Technology Co.,	2	0	2021-06-10
Tangshan Hongyun Healthcare Products Co., Ltd.	2	0	2021-09-27
Yunnan Huazhiyuan Medical Technology Co., Ltd.	2	0	2021-09-23
Medline Industries, Inc.	2	0	2020-10-26
Shandong Zhushi Pharmaceutical Group Co., Ltd.	1	0	2021-02-26
Shandong Hongxin Chemicals Co., Ltd.	1	0	2021-11-26
Anqing Pukang Medical Technology Co., Ltd.	1	0	2024-05-20
Jiangsu Cureguard Glove Co., Ltd.	1	0	2021-08-08
Viet Phu Trade and Import Export Co., Ltd.	1	1	2025-10-27
Shanghai Shengda Medical Applications Co., Ltd.	1	0	2021-11-04
Lutai Medical Technology Co., Ltd.	1	0	2021-03-12
Hebei Titans Hongsen Medical Technology Co., Ltd.	1	0	2021-07-29
Hebei Astro Medical Supply Co., Ltd.	1	0	2022-01-05
Tangshan Hongyun Plastic Products Co., Ltd.	1	0	2021-08-24
Shandong Langtai International Trade Co., Ltd.	1	0	2021-12-23
Jiangsu Huayuan Medical Technology Co., Ltd.	1	0	2021-06-23
Guangdong Kingfa Sci. & Tech.Co., Ltd.	1	0	2023-03-25
Better Health Medical Products Co., Ltd.	1	0	2020-10-16
Inner Mongolia Cureguard Medical Materials Co., Ltd.	1	0	2021-06-16
Chifeng Huawei Medical Science&Technology Co., Ltd.	1	0	2022-06-16
Shandong Shangwei Medical Products Co., Ltd.	1	0	2021-05-14

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
A4016	HCPCS	—	High	HCPCS code for vinyl or polymer examination gloves, per 100 gloves

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-07	K260860	Basic Medical Technology, Inc.	Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
2025-10-27	K252467	Viet Phu Trade and Import Export Co., Ltd.	Disposable Vinyl Examination Gloves
2025-08-28	K252505	Basic Medical Technology, Inc.	Powder-Free Vinyl Exam Gloves, clear
2024-05-20	K241252	Anqing Pukang Medical Technology Co., Ltd.	Disposable Vinyl Examination Gloves
2023-03-25	K230046	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Vinyl examination gloves
2023-02-06	K221980	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
2022-10-19	K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
2022-10-08	K223008	Jiangxi Handspro Products Solutions Co., Ltd.	Disposable Vinyl Examination Gloves
2022-09-28	K222442	Anhui Bytech Medical Supplies Co., Ltd.	DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
2022-08-25	K220055	Dezhou Hengchang Medical Technology Co., Ltd.	Disposable, vinyl examination gloves, Yellow
2022-06-16	K220469	Chifeng Huawei Medical Science&Technology Co., Ltd.	Disposable Vinyl Examination Glove
2022-03-31	K220240	Grand Work Plastic Products Co., Ltd.	Vinyl Co-Polymer Powder-free Examination Gloves, Black
2022-02-18	K213634	Dezhou Hengchang Medical Technology Co., Ltd.	Vinyl/Nitrile Blend Exam Glove
2022-02-17	K213625	Dezhou Hengchang Medical Technology Co., Ltd.	Vinyl Examination Gloves
2022-02-14	K212011	Top Glove Vietnam Company Limited	Vinyl Powder Free Examination Glove
2022-01-05	K213019	Hebei Astro Medical Supply Co., Ltd.	Vinyl Exam Gloves
2021-12-23	K212436	Shandong Langtai International Trade Co., Ltd.	NBR Synthetic Nitrile Examination Gloves
2021-12-22	K213144	Shen Wei USA, Inc.	Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors
2021-12-21	K213006	Taian Hengchang Medical Technology Co., Ltd.	Vinyl Examination Gloves
2021-12-20	K211865	Liao Ning Shangwei Medical Products Co., Ltd.	Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
2021-12-11	K212899	Bytech(Dongtai) Co., Ltd.	Disposable Vinyl/Nitrile Blend Medical Examination Gloves
2021-11-26	K212488	Shandong Hongxin Chemicals Co., Ltd.	Synthetic Nitrile Examination Gloves
2021-11-04	K211103	Shanghai Shengda Medical Applications Co., Ltd.	Powder Free Vinyl Examination Gloves
2021-10-24	K211698	Liuping Trading Co., Ltd.	Vinyl Examination Gloves(Yellow)
2021-09-27	K211236	Tangshan Hongyun Healthcare Products Co., Ltd.	Disposable Vinyl Examination Gloves