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Panels › General Hospital › Product code LZA · Class 1

Polymer Patient Examination Glove

Regulation 880.6250

17510(k)s in 12 months (1,182 all time)
3recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in LZA

Company510(k)sRecalls
Shen Wei (Usa), Inc.340
Hartalega Sdn Bhd330
Hartalega NGC Sdn. Bhd.240
Smart Glove Corp. Sdn Bhd190
Siam Sempermed Corp., Ltd.170
Yty Industry (Manjung) Sdn Bhd170
Gx Corporation Sdn Bhd150
Wrp Asia Pacific Sdn. Bhd.150
Eco Medi Glove Sdn. Bhd.140
O&M Halyard, Inc.140
Decided510(k)Device and applicantCode
Apr 16, 2021K202419BIOTECH Nitrile Examination Gloves
Tk Hitech Technology Co., Ltd., TH
LZA
Apr 7, 2021K210106Nitrile Examination Gloves
Zhenjiang Huayang Latex Products Co., Ltd., CN
LZA
Mar 31, 2021K210057Blue Nitrile Exam Glove, Powder Free
Real Star Medical Technology Co., Ltd., CN
LZA
Mar 30, 2021K210058Blue Nitrile Exam Glove, Powder Free
Great Harvest Trading Co., Ltd., CN
LZA
Mar 25, 2021K202083Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for
Shen Wei USA, Inc.
LZA
Mar 24, 2021K202080Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
Shen Wei USA, Inc.
LZA
Mar 19, 2021K203593Patient Examination Gloves
Guangdong Kingfa Sci. & Tech.Co., Ltd., CN
LZA
Mar 19, 2021K202081Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
Shen Wei USA, Inc.
LZA
Mar 17, 2021K202082Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential C
Shen Wei USA, Inc.
LZA
Mar 16, 2021K202086Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange,
Shen Wei USA, Inc.
LZA
Mar 5, 2021K202078Biodegradable Thermoplastic Elastomer Examination (TPE) Glove
Shen Wei USA, Inc.
LZA
Mar 5, 2021K202076Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors
Shen Wei USA, Inc.
LZA
Mar 2, 2021K202356Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)
Kanglongda Vietnam Protection Technology Company Limited, VN
LZA
Mar 1, 2021K202402Nitrile Examination Gloves (Blue, Violet Blue, White)
Jiangsu Tianshuo Medical Products Co., Ltd., CN
LZA
Feb 24, 2021K202003Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance
Gmp Medicare Sdn. Bhd., MY
LZA
Feb 12, 2021K203191LYDUS Nitrile Examination Gloves, Powder Free
Nathan Trading Co., Ltd., TH
LZA
Jan 7, 2021K202622Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fenta
O&M Halyard, Inc.
LZA
Dec 2, 2020K202384Palm Care Blue Nitrile Examination Gloves Powder Free
Hi-Care Thai Gloves Co. , Ltd., TH
LZA
Nov 30, 2020K202416Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Ga
Kimberly Clark Corporation
LZA
Oct 26, 2020K200150Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
Medline Industries, Inc.
LZA
Sep 22, 2020K200843Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs
O&M Halyard, Inc.
LZA
Sep 3, 2020K192111Biodegradable Nitrile Examination Powder Free Glove, Green
Top Glove Sdn. Bhd., MY
LZA
Aug 25, 2020K201772Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs an
Hartalega NGC Sdn. Bhd., MY
LZA
Aug 20, 2020K200093Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug
Anhui Lntco Medical Products Co., Ltd., CN
LZA
Aug 5, 2020K201531Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega Sdn Bhd, MY
LZA
Aug 5, 2020K201530Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)
Hartalega NGC Sdn. Bhd., MY
LZA
Aug 4, 2020K193666Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff; Powder-Free
Medline Industries, Inc.
LZA
Jul 13, 2020K200960Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
Medline Industires, Inc.
LZA
Jun 19, 2020K200671Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
Ansell Healthcare Products, LLC
LZA
Jun 19, 2020K192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LZA
Jun 6, 2020K200967mCare(R) Powder Free Nitrile Orange Examination Gloves
Mercator Medical (Thailand), Ltd., TH
LZA
Jun 5, 2020K193150Latex Examination Powder Free Glove, Aloe Vera
Top Glove Sdn. Bhd., MY
LZA
May 1, 2020K200453NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUG
Yty Industry (Manjung) Sdn Bhd, MY
LZA
Apr 25, 2020K200581Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega NGC Sdn. Bhd., MY
LZA
Apr 15, 2020K200181Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Comfort Rubber Gloves Industries Sdn. Bhd., MY
LZA
Apr 10, 2020K200072KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastr
Kimberly-Clark Corporation
LZA
Apr 9, 2020K200539Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
Sri Trang Gloves (Thailand) Public Company Limited, TH
LZA
Apr 9, 2020K200326Powder Free Nitrile Examination Glove (Aqua Green)
Riverstone Resources Sdn Bhd, MY
LZA
Apr 6, 2020K200019Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powd
Hartalega NGC Sdn. Bhd., MY
LZA
Mar 20, 2020K193581Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nit
Sri Trang Gloves (Thailand) Public Company Limited, TH
LZA
Mar 20, 2020K193121GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Dru
Eco Medi Glove Sdn. Bhd., MY
LZA
Mar 17, 2020K191753Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)
Medline Industries, Inc.
LZA
Mar 13, 2020K192241Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemothera
O&M Haylard, Inc.
LZA
Jan 24, 2020K192333Blue Nitrile Examination Gloves Powder Free
Jr Engineering & Medical Technologies (M) Sdn. Bhd., MY
LZA
Jan 17, 2020K192635Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
Wrp Asia Pacific Sdn. Bhd., MY
LZA
Jan 10, 2020K192315Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemoth
Medline Industries, Inc.
LZA
Jan 7, 2020K190942Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
Ever Growth (Vietnam) Co. , Ltd., VN
LZA
Dec 31, 2019K192444mCare® Powder Free Nitrile Black Examination Glove
Mercator Medical (Thailand), Ltd., TH
LZA
Dec 23, 2019K192104Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)
Medline Industries, Inc.
LZA
Dec 23, 2019K190860Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder
Ever Growth (Vietnam) Co. , Ltd., VN
LZA

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