Chrysalis Intelligence · Product Codes · LZA

LZA · Unclassified

440 clearances · 272 unique sponsors

Device class
Regulation —
Total clearances
440
2020-01-07 → 2026-07-21
Last 12 months
12
Unique sponsors
272
Medical specialty
Review panel
Regulation number
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
O&M Halyard, Inc. 13 1 2026-07-21
Hartalega NGC Sdn. Bhd. 11 3 2026-07-20
Shen Wei USA, Inc. 11 0 2022-05-28
Central Medicare Sdn Bhd 7 0 2023-10-02
Onetexx Sdn Bhd 7 0 2022-10-18
Guangdong Kingfa Sci. & Tech.Co., Ltd. 6 0 2023-04-27
Basic Medical Technology, Inc. 6 1 2026-01-23
Better Care Plastic Technology Co., Ltd. 6 0 2025-03-18
Mah Sing Healthcare Sdn. Bhd. 5 0 2025-06-06
Grand Work Plastic Products Co., Ltd. 5 0 2023-08-09
Shanxi Hongjin Plastic Technology Co., Ltd. 5 0 2023-10-20
Jiangsu Cureguard Glove Co., Ltd. 5 0 2022-10-01
Careglove Global Sdn. Bhd. 5 0 2025-04-01
Eco Medi Glove Sdn. Bhd. 5 0 2024-02-26
Hong Seng Gloves Sdn Bhd 4 0 2022-08-30
Jr Engineering & Medical Technologies (M) Sdn. Bhd. 4 0 2022-12-07
One Glove Industrial Sdn Bhd 4 0 2022-06-17
Comfort Rubber Gloves Industries Sdn. Bhd. 4 0 2024-10-25
Medline Industries, Inc. 4 0 2020-10-26
Sri Trang Gloves (Thailand) Public Company Limited 4 0 2024-05-13
Safeskin Retailing (Hk) Limited 4 0 2022-12-03
S&S Glove Corporation 3 1 2026-06-03
Huayuan Medical Technology(Shangqiu) Co., Ltd. 3 0 2021-12-18
Ksg Medicare Sdn. Bhd. 3 0 2024-09-11
Kanglongda Vietnam Protection Technology Company Limited 3 1 2026-06-18
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
2026-07-21 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
2025-06-17 K243133 Kl-Kepong Rubber Products Sdn. Bhd. Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid
2025-06-06 K243694 Mah Sing Healthcare Sdn. Bhd. Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
2025-06-03 K243796 Glove One, LLC GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
2025-05-22 K250630 Basic Medical Technology, Inc. Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
2025-04-23 K250944 Gmp Medicare Sdn. Bhd. Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl