Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LZC — Predicate Candidate Screening

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

133 daysmedian FDA review time
285 days90th percentile
79clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealth2026-01-141730
K243959Powder Free Nitrile Examination Gloves (Violet, Black, GreenLingshi Hongruida Health Protection Technology Co., Ltd.2025-02-24630
K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.2022-08-301310
K222449Nitrile Powder Free Examination Gloves, Tested For Use With Better Care Plastic Technology Co., Ltd.2022-08-27120
K220545Powder Free Nitrile Examination Gloves, Blue, Tested for useHl Rubber Industries Sdn Bhd2022-05-26900
K220491Disposable Medical Nitrile Examination Gloves -Tested for UsHainan Asther Medical Equipment Co., Ltd.2022-05-14810
K220353Disposal Medical Nitrile Examination Gloves-Tested for Use wNiujian Technology Co., Ltd.2022-03-31510
K213910Disposable Medical Nitrile Examination Gloves- Tested for UsChangzhou Universal Medical Equipment Co., Ltd.2022-03-10850
K213325Disposable Medical Nitrile Examination Gloves- Tested for UsAnhui Xinyisheng Medical Technology Co.,Ltd2022-01-281150
K213076AspenMed+Aspen Glove Sdn. Bhd.2021-12-20880
K212639Disposable Medical Nitrile Examination Gloves (Non sterile)Jiangsu Nanfang Medical Co., Ltd.2021-12-081100
K212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested Jr Engineering & Medical Technologies (M) Sdn. Bhd.2021-12-06940
K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard P0 & M Halyard, Inc.2020-10-112150
K201390Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested fMedline Industires, Inc.2020-09-181140
K193555Disposable Powder Free Nitrile Examination Glove, Blue ColorEver Global (Vietnam) Enterprise Corp2020-06-041670
K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard SO&M Halyard, Inc.2019-11-081840
K183562Powder-Free Nitrile Examination Glove (White Colored, Blue CEncompass Industries Sdn. Bhd.2019-10-233070
K182382Nitrile Examination Powder Free Glove, Aloe Vera, Blue, NitrGmp Medicare Sdn Bhd (F25)2019-08-293630
K183149Blue Non-Sterile Powder Free Nitrile Examination Gloves, TesCentral Medicare Sdn Bhd2019-07-042330
K190159Showa(R) Medical Exam Glove (Green) powder-free, disposable Showa Best Glove, Inc.2019-05-06960
K182383Non-Sterile, PF Nitrile Examination Gloves, Tested for Use wYty Industry (Manjung) Sdn Bhd2019-03-192000
K183132Halyard Pink Underguard Nitrile Powder-Free Exam Glove TesteO&M Halyard, Inc.2019-02-05840
K181130Powder Free Blue Nitrile Examination Gloves, Tested for Use Hebei Titans Hongsen Medical Technology Co., Ltd.2018-08-101020
K173766PF Nitrile Exam Glove with pH coating, Black-Gray Color, TesShen Wei USA, Inc.2018-07-082090
K180646Halyard Lavender Nitrile Powder-Free Exam Glove Tested for UHalyard Health2018-06-271070
K180476Powder Free Nitrile Examination Gloves Tested for Use with CComfort Rubber Gloves Industries Sdn. Bhd.2018-05-15820
K172864Non-Sterile Powder Free Blue Nitrile Examination Gloves TestMaxter Glove Manufacturing Sdn Bhd2018-05-022240
K173942Blue Non Sterile powder free Nitrile Examination Gloves TestCentral Medicare Sdn Bhd2018-03-05690
K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd2017-11-28880
K172525Blue Non Sterile Powder Free Nitrile Examination Gloves TestCentral Medicare Sdn Bhd2017-11-13840
K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHCareplus (M) Sdn Bhd2017-07-242850
K162186BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE,Brightway Holdings Sdn. Bhd.2017-03-312390
K163017Nitrile Blue Powder Free Examination Gloves with Low DermatiGmp Medicare Sdn. Bhd.2017-03-221450
K163146POWDER FREE Blue Nitrile GLOVES, Tested for Use with ChemothHebei Hongsen Plastics Technology Co, Ltd.2017-02-13960
K160709HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam GlovesHalyard Health2016-09-061760
K151390Powder Free Nitrile Examination Gloves Tested For Use With CMaxter Glove Manufacturing Sdn Bhd2016-05-023420
K152222NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use wGmp Medicare Sdn Bhd (F25)2016-04-212580
K141982DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVEWrp Asia Pacific Sdn. Bhd.2015-02-051990
K121811POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVESShen Wei (Usa), Inc.2012-11-211540
K121926BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WNorthstar Healthcare Holdings2012-09-20800
K120336NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE Hartalega Sdn Bhd2012-06-251430
K102189POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELatexx Manufacturing Sdn.Bhd.2012-03-145900
K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED Perusahaan Getah Asas Sdn. Bhd.2010-11-29630
K101822NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTSgmp Co., Ltd.2010-11-191420
K101436PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE Shen Wei (Usa), Inc.2010-11-171770
K101596KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTKimberly-Clark2010-07-21430
K093500POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) Wear Safe (Malaysia) Sdn. Bhd.2010-01-19680
K091643POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WGx Corporation Sdn Bhd2009-11-021510
K083410POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USEWrp Asia Pacific Sdn. Bhd.2009-07-312550
K083408POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR UWrp Asia Pacific Sdn. Bhd.2009-07-312550

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