Panels › General Hospital › Product code LZC · Class 1
Medical Glove, Specialty
Regulation 880.6250
1510(k)s in 12 months (79 all time)
1recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in LZC
| Company | 510(k)s | Recalls |
|---|---|---|
| Wrp Asia Pacific Sdn. Bhd. | 5 | 0 |
| Ansell Healthcare Products LLC | 0 | 4 |
| Central Medicare Sdn Bhd | 4 | 0 |
| O&M Halyard, Inc. | 2 | 2 |
| Cardinalhealth | 3 | 0 |
| Perusahaan Getah Asas Sdn. Bhd. | 3 | 0 |
| Shen Wei (Usa), Inc. | 3 | 0 |
| Acufex Microsurgical, Inc. | 2 | 0 |
| Gmp Medicare Sdn Bhd (F25) | 2 | 0 |
| Guardian Group, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 14, 2026 | K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff Cardinalhealth | LZC |
| Feb 24, 2025 | K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate Lingshi Hongruida Health Protection Technology Co., Ltd., CN | LZC |
| Aug 30, 2022 | K221157 | JR Medic Jr Engineering & Medical Technologies (M) Sdn. Bhd., MY | LZC |
| Aug 27, 2022 | K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Better Care Plastic Technology Co., Ltd., CN | LZC |
| May 26, 2022 | K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs Hl Rubber Industries Sdn Bhd, MY | LZC |
| May 14, 2022 | K220491 | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs Hainan Asther Medical Equipment Co., Ltd., CN | LZC |
| Mar 31, 2022 | K220353 | Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs Niujian Technology Co., Ltd., CN | LZC |
| Mar 10, 2022 | K213910 | Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs Changzhou Universal Medical Equipment Co., Ltd., CN | LZC |
| Jan 28, 2022 | K213325 | Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs Anhui Xinyisheng Medical Technology Co.,Ltd, CN | LZC |
| Dec 20, 2021 | K213076 | AspenMed+ Aspen Glove Sdn. Bhd., MY | LZC |
| Dec 8, 2021 | K212639 | Disposable Medical Nitrile Examination Gloves (Non sterile) Jiangsu Nanfang Medical Co., Ltd., CN | LZC |
| Dec 6, 2021 | K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs Jr Engineering & Medical Technologies (M) Sdn. Bhd., MY | LZC |
| Oct 11, 2020 | K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove 0 & M Halyard, Inc. | LZC |
| Sep 18, 2020 | K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) Medline Industires, Inc. | LZC |
| Jun 4, 2020 | K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrat Ever Global (Vietnam) Enterprise Corp, VN | LZC |
| Nov 8, 2019 | K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves O&M Halyard, Inc. | LZC |
| Oct 23, 2019 | K183562 | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Encompass Industries Sdn. Bhd., MY | LZC |
| Aug 29, 2019 | K182382 | Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink Gmp Medicare Sdn Bhd (F25), MY | LZC |
| Jul 4, 2019 | K183149 | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resi Central Medicare Sdn Bhd, MY | LZC |
| May 6, 2019 | K190159 | Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove Showa Best Glove, Inc. | LZC |
| Mar 19, 2019 | K182383 | Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue Yty Industry (Manjung) Sdn Bhd, MY | LZC |
| Feb 5, 2019 | K183132 | Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs O&M Halyard, Inc. | LZC |
| Aug 10, 2018 | K181130 | Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs Hebei Titans Hongsen Medical Technology Co., Ltd., CN | LZC |
| Jul 8, 2018 | K173766 | PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs Shen Wei USA, Inc. | LZC |
| Jun 27, 2018 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Halyard Health | LZC |
| May 15, 2018 | K180476 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Comfort Rubber Gloves Industries Sdn. Bhd., MY | LZC |
| May 2, 2018 | K172864 | Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Maxter Glove Manufacturing Sdn Bhd, MY | LZC |
| Mar 5, 2018 | K173942 | Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Central Medicare Sdn Bhd, MY | LZC |
| Nov 28, 2017 | K172642 | Orange Non Sterile Powder Free Nitrile Examination Gloves Central Medicare Sdn Bhd, MY | LZC |
| Nov 13, 2017 | K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Central Medicare Sdn Bhd, MY | LZC |
| Jul 24, 2017 | K162858 | NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST Careplus (M) Sdn Bhd, MY | LZC |
| Mar 31, 2017 | K162186 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM Brightway Holdings Sdn. Bhd., MY | LZC |
| Mar 22, 2017 | K163017 | Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Dru Gmp Medicare Sdn. Bhd., MY | LZC |
| Feb 13, 2017 | K163146 | POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs Hebei Hongsen Plastics Technology Co, Ltd., CN | LZC |
| Sep 6, 2016 | K160709 | HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves Halyard Health | LZC |
| May 2, 2016 | K151390 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Maxter Glove Manufacturing Sdn Bhd, MY | LZC |
| Apr 21, 2016 | K152222 | NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs Gmp Medicare Sdn Bhd (F25), MY | LZC |
| Feb 5, 2015 | K141982 | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Wrp Asia Pacific Sdn. Bhd., MY | LZC |
| Nov 21, 2012 | K121811 | POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES Shen Wei (Usa), Inc. | LZC |
| Sep 20, 2012 | K121926 | BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM Northstar Healthcare Holdings, IE | LZC |
| Jun 25, 2012 | K120336 | NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U Hartalega Sdn Bhd, MY | LZC |
| Mar 14, 2012 | K102189 | POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM Latexx Manufacturing Sdn.Bhd. | LZC |
| Nov 29, 2010 | K102790 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG Perusahaan Getah Asas Sdn. Bhd., MY | LZC |
| Nov 19, 2010 | K101822 | NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS Sgmp Co., Ltd. | LZC |
| Nov 17, 2010 | K101436 | PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) Shen Wei (Usa), Inc. | LZC |
| Jul 21, 2010 | K101596 | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- Kimberly-Clark | LZC |
| Jan 19, 2010 | K093500 | POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE Wear Safe (Malaysia) Sdn. Bhd., MY | LZC |
| Nov 2, 2009 | K091643 | POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Gx Corporation Sdn Bhd, MY | LZC |
| Jul 31, 2009 | K083410 | POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM Wrp Asia Pacific Sdn. Bhd., MY | LZC |
| Jul 31, 2009 | K083408 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS Wrp Asia Pacific Sdn. Bhd., MY | LZC |
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