LZA

Polymer Patient Examination Glove

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (82)

Last three years. Most recent: 2026-08-18.

NumberDecision dateApplicantDevice nameSummary
K2607942026-08-18Kossan International Sdn BhdNON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION …
K2620142026-07-21O&M Halyard, Inc.PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PU…PDF
K2542852026-07-20Hartalega NGC Sdn. Bhd.Nitrile Powder Free Examination Gloves Tested for Us…PDF
K2521172026-06-24Sw Technologies, Inc.Biodegradable Powder Free Nitrile Examination Glove,…
K2538242026-06-18Kanglongda Vietnam Protection Technolo…Powder Free Nitrile Examination Gloves Non-Sterile B…PDF
K2608672026-06-17Hartalega NGC Sdn. Bhd.Nitrile Powder Free Examination Gloves Tested for Us…PDF
K2607032026-06-03S&S Glove CorporationPowder Free Blue Nitrile Examination Glove - Tested …PDF
K2608062026-06-03Vista Industries,, LLCNitrile Disposable Examination GlovesPDF
K2531602026-01-23Basic Medical Technology, Inc.Syntex Exam GlovesPDF
K2525492026-01-13Kossan International Sdn BhdNon-sterile Powder Free Nitrile Examination Glove, D…
K2511412025-11-17Mercator Medical (Thailand), Ltd.Powder Free Nitrile Patient Examination Glove, Blue …
K2508612025-10-23Hartalega NGC Sdn. Bhd.Nitrile Powder Free Examination Glove Tested for Use…PDF
K2520752025-10-17Program Insite, LLCProgram insite® Powder-Free, Disposable Nitrile Exam…PDF
K2517162025-08-27Basic Medical Technology, Inc.Nitrile Powder-Free Exam Gloves Tested for Use with …PDF
K2522442025-08-21Ever Global (Vietnam) Enterprise Corpo…Disposable Powder Free Nitrile Examination Glove, Bl…PDF
K2436042025-08-18O&M Halyard, Inc.Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves…FDA
K2513192025-07-30Hartalega NGC Sdn. Bhd.Sterile Nitrile Powder Free Examination Glove Tested…PDF
K2501932025-07-09Basic Medical Technology, Inc.Nitrile Powder-Free Exam Gloves 2.8, Tested for Use …
K2503422025-07-08Encompass Industries Sdn. Bhd.Powder-Free Polychloroprene Examination Glove (Green…PDF
K2504962025-07-07Zibo Shengkun Chemical Industry Co., L…Powder Free Polyurethane Examination Gloves (Green, …
K2431722025-06-18O&M Halyard, Inc.Halyard Purple Nitrile* Powder-Free Exam Gloves, Ste…PDF
K2431332025-06-17Kl-Kepong Rubber Products Sdn. Bhd.Nitrile Powder Free Examination Gloves with Low Derm…PDF
K2436942025-06-06Mah Sing Healthcare Sdn. Bhd.Nitrile Powder Free Examination Glove with Tremella …PDF
K2437962025-06-03Glove One, LLCGLOVEONE™ Powder-Free Nitrile Examination Gloves – N…PDF
K2506302025-05-22Basic Medical Technology, Inc.Nitrile Powder-Free Exam Gloves with Hyaluronic Acid…PDF
K2509442025-04-23Gmp Medicare Sdn. Bhd.Nitrile Powder Free Examination Glove, Blue Tested f…
K2505782025-04-01Careglove Global Sdn. Bhd.Nitrile Examination Gloves Powder Free Tested for Us…PDF
K2505022025-03-19Safesource Direct, LLCSafeSource Direct Blue Powder-Free Nitrile Exam Glov…PDF
K2425332025-03-18Better Care Plastic Technology Co., Lt…Powder Free Nitrile Patient Examination Gloves, Blue…PDF
K2437922025-02-18Basic Medical Technology, Inc.Nitrile Powder-Free Exam Gloves Tested for Use with …PDF
K2440342025-02-06Ever Global (Vietnam) Enterprise Corpo…Disposable Powder Free Nitrile Examination Glove, Bl…PDF
K2434412025-01-31Basic Medical Technology, Inc.Nitrile Powder-Free Exam Gloves Tested for Use with …PDF
K2429362025-01-15Sunray Medical Products, Inc.Powder Free Nitrile Examination Gloves (Blue, Black)…PDF
K2438182025-01-08Hartalega NGC Sdn. Bhd.Nitrile Powder Free Examination Glove Tested for Use…PDF
K2425582024-12-17O&M Halyard, Inc.Halyard Black Nitrile Powder-Free Exam Gloves with T…PDF
K2402692024-10-25Comfort Rubber Gloves Industries Sdn. …Nitrile Powder Free Examination Gloves Biodegradable…PDF
K2428122024-10-12Nb Medical Company LimitedNITRILE EXAMINATION GLOVES (Tested For Use With Chem…PDF
K2419092024-09-27O&M Halyard, Inc.Halyard Purple Nitrile* Powder-Free Exam Gloves, Low…PDF
K2417452024-09-11Ksg Medicare Sdn. Bhd.Powder Free Nitrile Examination Glove, Non-sterile, …
K2405452024-08-28Genabio Diagnostics, Inc.GenaCheck™ Nitrile Powder Free Examination Glove Tes…PDF
K2417802024-08-23Cardinal Health200, LLCCardinal Health Nitrile Exam Gloves
K2415282024-08-06Comfort Rubber Gloves Industries Sdn. …Nitrile Powder Free Examination Gloves (Blue), Non-S…PDF
K2419702024-08-02Kanglongda Vietnam Protection Technolo…Powder Free Nitrile Examination Gloves (Blue), Teste…PDF
K2409302024-07-02Sri Trang Gloves Thailand (Public Comp…Non-sterile, Powder-Free Nitrile Examination Glove T…
K2408242024-06-25Ningxia Qiaoen Medical Technology Co.,…Disposable Medical Nitrile Examination Gloves (Non s…
K2406292024-05-28Xingyu Medical Tech Co., Ltd.Nitrile Disposable Examination Gloves, Tested for Us…PDF
K2326142024-05-13Sri Trang Gloves (Thailand) Public Com…Non-sterile, Powder-Free Nitrile Examination Glove T…
K2323192024-04-22Ug Global Resources Sdn. Bhd.Black Pearl Nitrile Examination GlovePDF
K2400212024-04-08Yue Kang Anhui Medical Products Co., L…Powder Free Nitrile Examination Glove 3.5, Blue Colo…PDF
K2403612024-04-04Hebei Titans Hongsen Medical Technolog…Powder Free Green Nitrile Examination Gloves (XS/S/M…PDF
K2400802024-04-02Syntex Healthcare Products Co., Ltd.Aloe Vera Nitrile Examination Gloves (Green) Tested …PDF
K2339902024-04-01Shandong Xingyu Gloves Co., Ltd.Nitrile Disposable Examination Gloves, Tested for Us…PDF
K2340972024-03-27Ever Growth (Vietnam) Corporation Limi…Disposable Powder Free Nitrile Examination Glove, Na…PDF
K2319382024-03-22O&M Halyard, Inc.Halyard STERLING* Nitrile Powder-Free Exam Gloves, L…FDA
K2326542024-03-20Nephron Nitrile, LLCNephron Nitrile™, Nitrile Powder-Free Examination Gl…FDA
K2313652024-03-01Anhui Intco Medical Products Co., Ltd.Nitrile Patient Examination Gloves with Hyaluronic A…PDF
K2400512024-02-29Lingshi Hongruida Health Protection Te…Powder Free Nitrile Examination Gloves (Blue), Teste…PDF
K2335602024-02-26Eco Medi Glove Sdn. Bhd.Powder Free Nitrile Examination Glove Blue with Low …PDF
K2337402024-02-13W.A. Rubbermate Co., Ltd.Black Nitrile Powder Free Patient Examination Glove,…PDF
K2400722024-02-09Luliang Hongruida Health Protection Te…Powder Free Nitrile Examination Gloves (Blue, Purple…PDF
K2327642024-02-07Eco Medi Glove Sdn. Bhd.Cornflower Blue Powder Free Nitrile Examination Glov…PDF
K2335982024-01-26Anhui Intco Medical Products Co., Ltd.Powder Free Nitrile Examination Glove 2.8 Blue Color…PDF
K2339702024-01-16Nephron Nitrile, LLCNephron Nitrile™, Nitrile Powder-Free Examination Bl…PDF
K2335202024-01-12Anhui Powerguard Technology Co., Ltd.Powder free, Non-sterile, Blue Nitrile Examination G…PDF
K2334052023-12-28Eco Medi Glove Sdn. Bhd.Blue Powder Free Nitrile Examination Glove with Chem…PDF
K2331822023-12-15Zibo Kaiyue Mould Technology Co., Ltd.Powder Free Nitrile Examination Gloves (Blue, White,…
K2330422023-12-06Shandong Intco Medical Products Co, Lt…Sterile Nitrile Examination Gloves Powder Free Teste…FDA
K2322522023-11-28Dehai (Shandong) Medical Gloves, Co., …Nitrile Powder Free Examination Gloves Tested for Us…PDF
K2325762023-11-21Jiangsu Complete Sincerity Medical New…Medical Nitrile Examination GlovesPDF
K2325382023-11-17Wrp Asia Pacific Sdn. Bhd.DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, …FDA
K2324612023-11-14Kossan International Sdn BhdPowder Free Nitrile Examination Glove, Pink Colored,…
K2322662023-11-03Better Care Plastic Technology Co., Lt…Powder Free Nitrile Patient Examination Gloves, Blue…FDA
K2310292023-10-30Zhonghong Pulin Medical Products Co., …Nitrile Exam Glove, Tested For Use With Chemotherapy…FDA
K2306622023-10-26Zhonghong Pulin Medical Products Co., …Nitrile Exam Glove, Extended cuff, Tested For Use Wi…PDF
K2325502023-10-20Shanxi Hongjin Plastic Technology Co.,…Nitrile Examination Gloves, Dual Color Black-BluePDF
K2320702023-10-11Better Care Plastic Technology Co., Lt…Biodegradable Nitrile Examination Gloves Tested for …PDF
K2307772023-10-063A Glove Sdn. Bhd.Patient Examination GlovesPDF
K2315672023-10-04Better Care Plastic Technology Co., Lt…Biodegradable Nitrile Powder Free Examination Gloves…FDA
K2306812023-10-02Central Medicare Sdn BhdBlue Non Sterile Powder Free Nitrile Examination Glo…
K2320642023-10-02Isikel Manufacturing, LLCPowder-Free Frost Nitrile Examination Gloves (Blue) …PDF
K2308472023-09-293A Glove Sdn. Bhd.Chemotherapy GlovesPDF
K2232142023-09-21Global Protection Corp.Powder-Free Nitrile Examination Gloves

58 summaries are archived here for direct download.

Official FDA classification page: LZA
Classification and pathway per current FDA publications. Data from openFDA (CC0).