Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LZA — Predicate Candidate Screening

1,175 FDA 510(k) clearances under this product code; the 50 most recent screened below.

94 daysmedian FDA review time
238 days90th percentile
1,175clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* O&M Halyard, Inc.2026-07-21360
K254285Nitrile Powder Free Examination Gloves Tested for Use with CHartalega NGC Sdn. Bhd.2026-07-202010
K252117Biodegradable Powder Free Nitrile Examination Glove, Blue CoSw Technologies, Inc.2026-06-243520
K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company Limited2026-06-181990
K260867Nitrile Powder Free Examination Gloves Tested for Use with CHartalega NGC Sdn. Bhd.2026-06-17920
K260703Powder Free Blue Nitrile Examination Glove - Tested for Use S&S Glove Corporation2026-06-03910
K260806Nitrile Disposable Examination GlovesVista Industries,, LLC2026-06-03830
K253160Syntex Exam GlovesBasic Medical Technology, Inc.2026-01-231190
K252549Non-sterile Powder Free Nitrile Examination Glove, Dual ColoKossan International Sdn Bhd2026-01-131530
K251141Powder Free Nitrile Patient Examination Glove, Blue colored,Mercator Medical (Thailand), Ltd.2025-11-172170
K250861Nitrile Powder Free Examination Glove Tested for Use with ChHartalega NGC Sdn. Bhd.2025-10-232160
K252075Program insite® Powder-Free, Disposable Nitrile Exam GlovesProgram Insite, LLC2025-10-171070
K251716Nitrile Powder-Free Exam Gloves Tested for Use with ChemotheBasic Medical Technology, Inc.2025-08-27840
K252244Disposable Powder Free Nitrile Examination Glove, Blue ColorEver Global (Vietnam) Enterprise Corporation2025-08-21340
K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low DeO&M Halyard, Inc.2025-08-182700
K251319Sterile Nitrile Powder Free Examination Glove Tested for UseHartalega NGC Sdn. Bhd.2025-07-30920
K250193Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with CheBasic Medical Technology, Inc.2025-07-091670
K250342Powder-Free Polychloroprene Examination Glove (Green Color) Encompass Industries Sdn. Bhd.2025-07-081520
K250496Powder Free Polyurethane Examination Gloves (Green, Blue, PiZibo Shengkun Chemical Industry Co., Ltd.2025-07-071370
K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile PaiO&M Halyard, Inc.2025-06-182610
K243133Nitrile Powder Free Examination Gloves with Low Dermatitis PKl-Kepong Rubber Products Sdn. Bhd.2025-06-172600
K243694Nitrile Powder Free Examination Glove with Tremella FuciformMah Sing Healthcare Sdn. Bhd.2025-06-061890
K243796GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-steriGlove One, LLC2025-06-031750
K250630Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and teBasic Medical Technology, Inc.2025-05-22800
K250944Nitrile Powder Free Examination Glove, Blue Tested for Use wGmp Medicare Sdn. Bhd.2025-04-23260
K250578Nitrile Examination Gloves Powder Free Tested for Use With CCareglove Global Sdn. Bhd.2025-04-01330
K250502SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERSafesource Direct, LLC2025-03-19270
K242533Powder Free Nitrile Patient Examination Gloves, Blue ColoredBetter Care Plastic Technology Co., Ltd.2025-03-182040
K243792Nitrile Powder-Free Exam Gloves Tested for Use with ChemotheBasic Medical Technology, Inc.2025-02-18700
K244034Disposable Powder Free Nitrile Examination Glove, Blue ColorEver Global (Vietnam) Enterprise Corporation2025-02-06380
K243441Nitrile Powder-Free Exam Gloves Tested for Use with ChemotheBasic Medical Technology, Inc.2025-01-31860
K242936Powder Free Nitrile Examination Gloves (Blue, Black), TestedSunray Medical Products, Inc.2025-01-151120
K243818Nitrile Powder Free Examination Glove Tested for Use with ChHartalega NGC Sdn. Bhd.2025-01-08270
K242558Halyard Black Nitrile Powder-Free Exam Gloves with Textured O&M Halyard, Inc.2024-12-171110
K240269Nitrile Powder Free Examination Gloves Biodegradable (Green)Comfort Rubber Gloves Industries Sdn. Bhd.2024-10-252680
K242812NITRILE EXAMINATION GLOVES (Tested For Use With ChemotherapyNb Medical Company Limited2024-10-12240
K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low DermatiO&M Halyard, Inc.2024-09-27880
K241745Powder Free Nitrile Examination Glove, Non-sterile, Tested fKsg Medicare Sdn. Bhd.2024-09-11850
K240545GenaCheck™ Nitrile Powder Free Examination Glove Tested for Genabio Diagnostics, Inc.2024-08-281830
K241780Cardinal Health Nitrile Exam GlovesCardinal Health200, LLC2024-08-23640
K241528Nitrile Powder Free Examination Gloves (Blue), Non-Sterile LComfort Rubber Gloves Industries Sdn. Bhd.2024-08-06680
K241970Powder Free Nitrile Examination Gloves (Blue), Tested for UsKanglongda Vietnam Protection Technology Company Limited2024-08-02280
K240930Non-sterile, Powder-Free Nitrile Examination Glove Tested foSri Trang Gloves Thailand (Public Company Limited)2024-07-02890
K240824Disposable Medical Nitrile Examination Gloves (Non sterile) Ningxia Qiaoen Medical Technology Co., Ltd.2024-06-25910
K240629Nitrile Disposable Examination Gloves, Tested for Use with CXingyu Medical Tech Co., Ltd.2024-05-28830
K232614Non-sterile, Powder-Free Nitrile Examination Glove Tested foSri Trang Gloves (Thailand) Public Company Limited2024-05-132590
K232319Black Pearl Nitrile Examination GloveUg Global Resources Sdn. Bhd.2024-04-222630
K240021Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-SYue Kang Anhui Medical Products Co., Ltd.2024-04-08960
K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Hebei Titans Hongsen Medical Technology Co., Ltd.2024-04-04580
K240080Aloe Vera Nitrile Examination Gloves (Green) Tested for Use Syntex Healthcare Products Co., Ltd.2024-04-02820

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda