Chrysalis Intelligence · Product Codes · LZA

LZA · Polymer Patient Examination Glove

General Hospital · 445 clearances · 274 unique sponsors

Device class
Class I
Regulation 880.6250
Total clearances
445
2020-01-07 → 2026-09-09
Last 12 months
17
Unique sponsors
274
Definition

What is Polymer Patient Examination Glove

A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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.
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.6250
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
O&M Halyard, Inc. 13 1 2026-07-21
Shen Wei USA, Inc. 11 0 2022-05-28
Hartalega NGC Sdn. Bhd. 11 3 2026-07-20
Onetexx Sdn Bhd 7 0 2022-10-18
Central Medicare Sdn Bhd 7 0 2023-10-02
Guangdong Kingfa Sci. & Tech.Co., Ltd. 6 0 2023-04-27
Better Care Plastic Technology Co., Ltd. 6 0 2025-03-18
Basic Medical Technology, Inc. 6 1 2026-01-23
Mah Sing Healthcare Sdn. Bhd. 5 0 2025-06-06
Jiangsu Cureguard Glove Co., Ltd. 5 0 2022-10-01
Eco Medi Glove Sdn. Bhd. 5 0 2024-02-26
Shanxi Hongjin Plastic Technology Co., Ltd. 5 0 2023-10-20
Careglove Global Sdn. Bhd. 5 0 2025-04-01
Grand Work Plastic Products Co., Ltd. 5 0 2023-08-09
Jr Engineering & Medical Technologies (M) Sdn. Bhd. 4 0 2022-12-07
Comfort Rubber Gloves Industries Sdn. Bhd. 4 0 2024-10-25
One Glove Industrial Sdn Bhd 4 0 2022-06-17
Sri Trang Gloves (Thailand) Public Company Limited 4 0 2024-05-13
Safeskin Retailing (Hk) Limited 4 0 2022-12-03
Medline Industries, Inc. 4 0 2020-10-26
Hong Seng Gloves Sdn Bhd 4 0 2022-08-30
Xingyu Medical Tech Co., Ltd. 3 0 2024-05-28
Riverstone Resources Sdn Bhd 3 0 2022-06-03
Yty Industry (Manjung) Sdn Bhd 3 0 2023-03-25
Wrp Asia Pacific Sdn. Bhd. 3 0 2023-11-17
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.

CodeTypeDescriptionConfidenceRationale
A4016 HCPCS — High HCPCS code for vinyl or polymer examination gloves (including nitrile), per 100 gloves
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-09-09 K262542 Top Glove Sdn. Bhd. Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim
2026-09-09 K261793 Maxter Healthcare, Inc. Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
2026-09-08 K260312 Gmp Medicare Sdn. Bhd. Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid
2026-09-02 K261749 Cardinalhealth Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
2026-08-18 K260794 Kossan International Sdn Bhd NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
2026-07-21 K262014 O&M Halyard, Inc. PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
2026-07-20 K254285 Hartalega NGC Sdn. Bhd. Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue
2026-06-24 K252117 Sw Technologies, Inc. Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
2026-06-18 K253824 Kanglongda Vietnam Protection Technology Company Limited Powder Free Nitrile Examination Gloves Non-Sterile Black
2026-06-17 K260867 Hartalega NGC Sdn. Bhd. Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
2026-06-03 K260806 Vista Industries,, LLC Nitrile Disposable Examination Gloves
2026-06-03 K260703 S&S Glove Corporation Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
2026-01-23 K253160 Basic Medical Technology, Inc. Syntex Exam Gloves
2026-01-13 K252549 Kossan International Sdn Bhd Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
2025-11-17 K251141 Mercator Medical (Thailand), Ltd. Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
2025-10-23 K250861 Hartalega NGC Sdn. Bhd. Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
2025-10-17 K252075 Program Insite, LLC Program insite® Powder-Free, Disposable Nitrile Exam Gloves
2025-08-27 K251716 Basic Medical Technology, Inc. Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
2025-08-21 K252244 Ever Global (Vietnam) Enterprise Corporation Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
2025-08-18 K243604 O&M Halyard, Inc. Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid
2025-07-30 K251319 Hartalega NGC Sdn. Bhd. Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff
2025-07-09 K250193 Basic Medical Technology, Inc. Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
2025-07-08 K250342 Encompass Industries Sdn. Bhd. Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
2025-07-07 K250496 Zibo Shengkun Chemical Industry Co., Ltd. Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
2025-06-18 K243172 O&M Halyard, Inc. Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles