LZA
- Product code
- LZA
- Device name
- Polymer Patient Examination Glove
- Device class
- Class 1
- 21 CFR
- 21 CFR 880.6250
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 82
- Summaries archived here
- 58 (direct download)
- 510(k) clearances (all years, FDA)
- 1176 (all years; only the last 3 years are listed here)
FDA classification definition
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.
510(k) clearances, last 3 years (82)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260794 | 2026-08-18 | Kossan International Sdn Bhd | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION … | — |
| K262014 | 2026-07-21 | O&M Halyard, Inc. | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PU… | |
| K254285 | 2026-07-20 | Hartalega NGC Sdn. Bhd. | Nitrile Powder Free Examination Gloves Tested for Us… | |
| K252117 | 2026-06-24 | Sw Technologies, Inc. | Biodegradable Powder Free Nitrile Examination Glove,… | — |
| K253824 | 2026-06-18 | Kanglongda Vietnam Protection Technolo… | Powder Free Nitrile Examination Gloves Non-Sterile B… | |
| K260867 | 2026-06-17 | Hartalega NGC Sdn. Bhd. | Nitrile Powder Free Examination Gloves Tested for Us… | |
| K260703 | 2026-06-03 | S&S Glove Corporation | Powder Free Blue Nitrile Examination Glove - Tested … | |
| K260806 | 2026-06-03 | Vista Industries,, LLC | Nitrile Disposable Examination Gloves | |
| K253160 | 2026-01-23 | Basic Medical Technology, Inc. | Syntex Exam Gloves | |
| K252549 | 2026-01-13 | Kossan International Sdn Bhd | Non-sterile Powder Free Nitrile Examination Glove, D… | — |
| K251141 | 2025-11-17 | Mercator Medical (Thailand), Ltd. | Powder Free Nitrile Patient Examination Glove, Blue … | — |
| K250861 | 2025-10-23 | Hartalega NGC Sdn. Bhd. | Nitrile Powder Free Examination Glove Tested for Use… | |
| K252075 | 2025-10-17 | Program Insite, LLC | Program insite® Powder-Free, Disposable Nitrile Exam… | |
| K251716 | 2025-08-27 | Basic Medical Technology, Inc. | Nitrile Powder-Free Exam Gloves Tested for Use with … | |
| K252244 | 2025-08-21 | Ever Global (Vietnam) Enterprise Corpo… | Disposable Powder Free Nitrile Examination Glove, Bl… | |
| K243604 | 2025-08-18 | O&M Halyard, Inc. | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves… | FDA |
| K251319 | 2025-07-30 | Hartalega NGC Sdn. Bhd. | Sterile Nitrile Powder Free Examination Glove Tested… | |
| K250193 | 2025-07-09 | Basic Medical Technology, Inc. | Nitrile Powder-Free Exam Gloves 2.8, Tested for Use … | — |
| K250342 | 2025-07-08 | Encompass Industries Sdn. Bhd. | Powder-Free Polychloroprene Examination Glove (Green… | |
| K250496 | 2025-07-07 | Zibo Shengkun Chemical Industry Co., L… | Powder Free Polyurethane Examination Gloves (Green, … | — |
| K243172 | 2025-06-18 | O&M Halyard, Inc. | Halyard Purple Nitrile* Powder-Free Exam Gloves, Ste… | |
| K243133 | 2025-06-17 | Kl-Kepong Rubber Products Sdn. Bhd. | Nitrile Powder Free Examination Gloves with Low Derm… | |
| K243694 | 2025-06-06 | Mah Sing Healthcare Sdn. Bhd. | Nitrile Powder Free Examination Glove with Tremella … | |
| K243796 | 2025-06-03 | Glove One, LLC | GLOVEONE Powder-Free Nitrile Examination Gloves N… | |
| K250630 | 2025-05-22 | Basic Medical Technology, Inc. | Nitrile Powder-Free Exam Gloves with Hyaluronic Acid… | |
| K250944 | 2025-04-23 | Gmp Medicare Sdn. Bhd. | Nitrile Powder Free Examination Glove, Blue Tested f… | — |
| K250578 | 2025-04-01 | Careglove Global Sdn. Bhd. | Nitrile Examination Gloves Powder Free Tested for Us… | |
| K250502 | 2025-03-19 | Safesource Direct, LLC | SafeSource Direct Blue Powder-Free Nitrile Exam Glov… | |
| K242533 | 2025-03-18 | Better Care Plastic Technology Co., Lt… | Powder Free Nitrile Patient Examination Gloves, Blue… | |
| K243792 | 2025-02-18 | Basic Medical Technology, Inc. | Nitrile Powder-Free Exam Gloves Tested for Use with … | |
| K244034 | 2025-02-06 | Ever Global (Vietnam) Enterprise Corpo… | Disposable Powder Free Nitrile Examination Glove, Bl… | |
| K243441 | 2025-01-31 | Basic Medical Technology, Inc. | Nitrile Powder-Free Exam Gloves Tested for Use with … | |
| K242936 | 2025-01-15 | Sunray Medical Products, Inc. | Powder Free Nitrile Examination Gloves (Blue, Black)… | |
| K243818 | 2025-01-08 | Hartalega NGC Sdn. Bhd. | Nitrile Powder Free Examination Glove Tested for Use… | |
| K242558 | 2024-12-17 | O&M Halyard, Inc. | Halyard Black Nitrile Powder-Free Exam Gloves with T… | |
| K240269 | 2024-10-25 | Comfort Rubber Gloves Industries Sdn. … | Nitrile Powder Free Examination Gloves Biodegradable… | |
| K242812 | 2024-10-12 | Nb Medical Company Limited | NITRILE EXAMINATION GLOVES (Tested For Use With Chem… | |
| K241909 | 2024-09-27 | O&M Halyard, Inc. | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low… | |
| K241745 | 2024-09-11 | Ksg Medicare Sdn. Bhd. | Powder Free Nitrile Examination Glove, Non-sterile, … | — |
| K240545 | 2024-08-28 | Genabio Diagnostics, Inc. | GenaCheck Nitrile Powder Free Examination Glove Tes… | |
| K241780 | 2024-08-23 | Cardinal Health200, LLC | Cardinal Health Nitrile Exam Gloves | — |
| K241528 | 2024-08-06 | Comfort Rubber Gloves Industries Sdn. … | Nitrile Powder Free Examination Gloves (Blue), Non-S… | |
| K241970 | 2024-08-02 | Kanglongda Vietnam Protection Technolo… | Powder Free Nitrile Examination Gloves (Blue), Teste… | |
| K240930 | 2024-07-02 | Sri Trang Gloves Thailand (Public Comp… | Non-sterile, Powder-Free Nitrile Examination Glove T… | — |
| K240824 | 2024-06-25 | Ningxia Qiaoen Medical Technology Co.,… | Disposable Medical Nitrile Examination Gloves (Non s… | — |
| K240629 | 2024-05-28 | Xingyu Medical Tech Co., Ltd. | Nitrile Disposable Examination Gloves, Tested for Us… | |
| K232614 | 2024-05-13 | Sri Trang Gloves (Thailand) Public Com… | Non-sterile, Powder-Free Nitrile Examination Glove T… | — |
| K232319 | 2024-04-22 | Ug Global Resources Sdn. Bhd. | Black Pearl Nitrile Examination Glove | |
| K240021 | 2024-04-08 | Yue Kang Anhui Medical Products Co., L… | Powder Free Nitrile Examination Glove 3.5, Blue Colo… | |
| K240361 | 2024-04-04 | Hebei Titans Hongsen Medical Technolog… | Powder Free Green Nitrile Examination Gloves (XS/S/M… | |
| K240080 | 2024-04-02 | Syntex Healthcare Products Co., Ltd. | Aloe Vera Nitrile Examination Gloves (Green) Tested … | |
| K233990 | 2024-04-01 | Shandong Xingyu Gloves Co., Ltd. | Nitrile Disposable Examination Gloves, Tested for Us… | |
| K234097 | 2024-03-27 | Ever Growth (Vietnam) Corporation Limi… | Disposable Powder Free Nitrile Examination Glove, Na… | |
| K231938 | 2024-03-22 | O&M Halyard, Inc. | Halyard STERLING* Nitrile Powder-Free Exam Gloves, L… | FDA |
| K232654 | 2024-03-20 | Nephron Nitrile, LLC | Nephron Nitrile, Nitrile Powder-Free Examination Gl… | FDA |
| K231365 | 2024-03-01 | Anhui Intco Medical Products Co., Ltd. | Nitrile Patient Examination Gloves with Hyaluronic A… | |
| K240051 | 2024-02-29 | Lingshi Hongruida Health Protection Te… | Powder Free Nitrile Examination Gloves (Blue), Teste… | |
| K233560 | 2024-02-26 | Eco Medi Glove Sdn. Bhd. | Powder Free Nitrile Examination Glove Blue with Low … | |
| K233740 | 2024-02-13 | W.A. Rubbermate Co., Ltd. | Black Nitrile Powder Free Patient Examination Glove,… | |
| K240072 | 2024-02-09 | Luliang Hongruida Health Protection Te… | Powder Free Nitrile Examination Gloves (Blue, Purple… | |
| K232764 | 2024-02-07 | Eco Medi Glove Sdn. Bhd. | Cornflower Blue Powder Free Nitrile Examination Glov… | |
| K233598 | 2024-01-26 | Anhui Intco Medical Products Co., Ltd. | Powder Free Nitrile Examination Glove 2.8 Blue Color… | |
| K233970 | 2024-01-16 | Nephron Nitrile, LLC | Nephron Nitrile, Nitrile Powder-Free Examination Bl… | |
| K233520 | 2024-01-12 | Anhui Powerguard Technology Co., Ltd. | Powder free, Non-sterile, Blue Nitrile Examination G… | |
| K233405 | 2023-12-28 | Eco Medi Glove Sdn. Bhd. | Blue Powder Free Nitrile Examination Glove with Chem… | |
| K233182 | 2023-12-15 | Zibo Kaiyue Mould Technology Co., Ltd. | Powder Free Nitrile Examination Gloves (Blue, White,… | — |
| K233042 | 2023-12-06 | Shandong Intco Medical Products Co, Lt… | Sterile Nitrile Examination Gloves Powder Free Teste… | FDA |
| K232252 | 2023-11-28 | Dehai (Shandong) Medical Gloves, Co., … | Nitrile Powder Free Examination Gloves Tested for Us… | |
| K232576 | 2023-11-21 | Jiangsu Complete Sincerity Medical New… | Medical Nitrile Examination Gloves | |
| K232538 | 2023-11-17 | Wrp Asia Pacific Sdn. Bhd. | DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, … | FDA |
| K232461 | 2023-11-14 | Kossan International Sdn Bhd | Powder Free Nitrile Examination Glove, Pink Colored,… | — |
| K232266 | 2023-11-03 | Better Care Plastic Technology Co., Lt… | Powder Free Nitrile Patient Examination Gloves, Blue… | FDA |
| K231029 | 2023-10-30 | Zhonghong Pulin Medical Products Co., … | Nitrile Exam Glove, Tested For Use With Chemotherapy… | FDA |
| K230662 | 2023-10-26 | Zhonghong Pulin Medical Products Co., … | Nitrile Exam Glove, Extended cuff, Tested For Use Wi… | |
| K232550 | 2023-10-20 | Shanxi Hongjin Plastic Technology Co.,… | Nitrile Examination Gloves, Dual Color Black-Blue | |
| K232070 | 2023-10-11 | Better Care Plastic Technology Co., Lt… | Biodegradable Nitrile Examination Gloves Tested for … | |
| K230777 | 2023-10-06 | 3A Glove Sdn. Bhd. | Patient Examination Gloves | |
| K231567 | 2023-10-04 | Better Care Plastic Technology Co., Lt… | Biodegradable Nitrile Powder Free Examination Gloves… | FDA |
| K230681 | 2023-10-02 | Central Medicare Sdn Bhd | Blue Non Sterile Powder Free Nitrile Examination Glo… | — |
| K232064 | 2023-10-02 | Isikel Manufacturing, LLC | Powder-Free Frost Nitrile Examination Gloves (Blue) … | |
| K230847 | 2023-09-29 | 3A Glove Sdn. Bhd. | Chemotherapy Gloves | |
| K223214 | 2023-09-21 | Global Protection Corp. | Powder-Free Nitrile Examination Gloves | — |
Official FDA classification page: LZA
Classification and pathway per current FDA publications. Data from openFDA (CC0).