LZC · Medical Glove, Specialty · Chrysalis Intelligence

Device class

Class I

Regulation 880.6250

Total clearances

2020-06-04 → 2026-01-14

Last 12 months

Unique sponsors

Definition

What is Medical Glove, Specialty

A disposable medical glove (examination or surgeons) 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.

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
Jr Engineering & Medical Technologies (M) Sdn. Bhd.	2	0	2022-08-30
Better Care Plastic Technology Co., Ltd.	1	0	2022-08-27
Niujian Technology Co., Ltd.	1	0	2022-03-31
Cardinalhealth	1	1	2026-01-14
Hl Rubber Industries Sdn Bhd	1	0	2022-05-26
Hainan Asther Medical Equipment Co., Ltd.	1	0	2022-05-14
Jiangsu Nanfang Medical Co., Ltd.	1	0	2021-12-08
0 & M Halyard, Inc.	1	0	2020-10-11
Anhui Xinyisheng Medical Technology Co.,Ltd	1	0	2022-01-28
Ever Global (Vietnam) Enterprise Corp	1	0	2020-06-04
Lingshi Hongruida Health Protection Technology Co., Ltd.	1	0	2025-02-24
Medline Industires, Inc.	1	0	2020-09-18
Changzhou Universal Medical Equipment Co., Ltd.	1	0	2022-03-10
Aspen Glove Sdn. Bhd.	1	0	2021-12-20

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 specialty medical examination or surgical gloves, per 100 gloves

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-01-14	K252313	Cardinalhealth	Cardinal Health Nitrile Examination Gloves Extended Cuff
2025-02-24	K243959	Lingshi Hongruida Health Protection Technology Co., Ltd.	Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
2022-08-30	K221157	Jr Engineering & Medical Technologies (M) Sdn. Bhd.	JR Medic
2022-08-27	K222449	Better Care Plastic Technology Co., Ltd.	Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
2022-05-26	K220545	Hl Rubber Industries Sdn Bhd	Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
2022-05-14	K220491	Hainan Asther Medical Equipment Co., Ltd.	Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
2022-03-31	K220353	Niujian Technology Co., Ltd.	Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
2022-03-10	K213910	Changzhou Universal Medical Equipment Co., Ltd.	Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs
2022-01-28	K213325	Anhui Xinyisheng Medical Technology Co.,Ltd	Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
2021-12-20	K213076	Aspen Glove Sdn. Bhd.	AspenMed+
2021-12-08	K212639	Jiangsu Nanfang Medical Co., Ltd.	Disposable Medical Nitrile Examination Gloves (Non sterile)
2021-12-06	K212827	Jr Engineering & Medical Technologies (M) Sdn. Bhd.	Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
2020-10-11	K200633	0 & M Halyard, Inc.	Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
2020-09-18	K201390	Medline Industires, Inc.	Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
2020-06-04	K193555	Ever Global (Vietnam) Enterprise Corp	Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate