LZC · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-06-04 → 2026-01-14

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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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
Cardinalhealth	1	1	2026-01-14
Niujian Technology Co., Ltd.	1	0	2022-03-31
Aspen Glove Sdn. Bhd.	1	0	2021-12-20
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
Hainan Asther Medical Equipment Co., Ltd.	1	0	2022-05-14
0 & M Halyard, Inc.	1	0	2020-10-11
Jiangsu Nanfang Medical Co., Ltd.	1	0	2021-12-08
Hl Rubber Industries Sdn Bhd	1	0	2022-05-26
Anhui Xinyisheng Medical Technology Co.,Ltd	1	0	2022-01-28
Ever Global (Vietnam) Enterprise Corp	1	0	2020-06-04

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

LZC · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances