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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
Jun 1, 2022K220488Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd., CN
LZA
May 31, 2022K212699Disposable Powder Free Polyethylene Examination Gloves
Mastermax Plastic (Huizhou), Ltd., CN
LZA
May 28, 2022K213141Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use wit
Shen Wei USA, Inc.
LZA
May 28, 2022K212584Blue Nitrile Examination Gloves Powder Free
Amazing Rubber Products Pvt, Ltd., IN
LZA
May 27, 2022K220609Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange an
Encompass Industries Sdn. Bhd., MY
LZA
May 26, 2022K220249Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
Grand Work Plastic Products Co., Ltd., CN
LZA
May 26, 2022K212629PP Care Nitrile Examination Gloves
Eg Group Product and Services Co., Ltd., TH
LZA
May 23, 2022K220155Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
Motex Healthcare (Anhui) Co., Ltd., CN
LZA
May 23, 2022K211810Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
Pt. Shamrock Manufacturing Corpora, ID
LZA
May 18, 2022K220211Nitrile Powder Free Examination Gloves
Hebei Kangxida Medical Technology Development Co., Ltd., CN
LZA
May 18, 2022K212408Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
Pt. Maja Agung Latexindo, ID
LZA
May 13, 2022K220429Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
One Glove Industrial Sdn Bhd, MY
LZA
May 12, 2022K220442Synguard Nitrile Exam Glove
Tianjin Aoshang Outdoor Equipment Co., Ltd., CN
LZA
May 12, 2022K220118Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves
Kl-Kepong Rubber Products Sdn. Bhd., MY
LZA
May 11, 2022K220250Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Grand Work Plastic Products Co., Ltd., CN
LZA
May 10, 2022K220428Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
One Glove Industrial Sdn Bhd, MY
LZA
May 10, 2022K220427White Nitrile Powder-Free Patient Examination Glove, Non Sterile
One Glove Industrial Sdn Bhd, MY
LZA
Apr 27, 2022K213040Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue
Guangdong Kingfa Sci. & Tech.Co., Ltd., CN
LZA
Apr 21, 2022K220382Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple
Jiangsu Bytech Medical Supplies Co., Ltd., CN
LZA
Apr 21, 2022K213681Ivory Glove Powder-Free Nitrile Examination Gloves
Ivory Gloves Sdn. Bhd., MY
LZA
Apr 17, 2022K213408BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
Meditech Gloves Sdn Bhd, MY
LZA
Apr 14, 2022K220561Disposable Medical Nitrile Examination Gloves
Nanjing Universal Medical Equipment Co., Ltd., CN
LZA
Apr 13, 2022K220375Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff,
Summit Glove, Inc.
LZA
Apr 13, 2022K220373Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous,
Summit Glove, Inc.
LZA
Apr 11, 2022K220209Powder Free Nitrile Examination Glove, Non-sterile (Blue)
Ksg Medicare Sdn. Bhd., MY
LZA
Apr 11, 2022K220121Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black
Aamedix Glove Sdn Bhd, MY
LZA
Apr 11, 2022K213437Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fe
Central Medicare Sdn Bhd, MY
LZA
Apr 9, 2022K220401Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim
Riverstone Resources Sdn Bhd, MY
LZA
Apr 9, 2022K212929Nitrile Examination Gloves
Watchtower Ppe Supplies, Inc.
LZA
Apr 3, 2022K220066Medical Nitrile Examination Gloves
Hunan Zhenheyikang Medical Instrument Co., Ltd., CN
LZA
Apr 3, 2022K213604ELAZ Nitrile Powder Free Examination Glove
Protect Gloves Co., Ltd., TH
LZA
Apr 2, 2022K220343Nitrile Examination Gloves
Nb Medical Co., Ltd., VN
LZA
Mar 31, 2022K213843Nitrile Examination Gloves
Dong Tai City Huayi Gloves Co., Ltd., CN
LZA
Mar 28, 2022K213662Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)
Taishan Weibang Medical Equipment Co., Ltd., CN
LZA
Mar 26, 2022K220229Powder Free Nitrile Examination Gloves, Orange
Shanxi Hongjin Plastic Technology Co., Ltd., CN
LZA
Mar 26, 2022K220215Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citr
Ksg Medicare Sdn. Bhd., MY
LZA
Mar 26, 2022K213729Clover Glove
Clover Glove Company Limited, TH
LZA
Mar 25, 2022K213848Medical nitrile examination gloves (Model: JL001)
Guangdong Jiali Pharmaceutical Co.,Ltd, CN
LZA
Mar 24, 2022K220354Disposable Medical Synthetic Nitrile Examination Gloves
Niujian Technology Co., Ltd., CN
LZA
Mar 24, 2022K212916Black Nitrile Powder Free Patient Examination Glove, Non Sterile
Rimba Glove Sdn Bhd, MY
LZA
Mar 22, 2022K213678Powder Free Blue Nitrile Examination Gloves
Lienteh Technology Sdn Bhd, MY
LZA
Mar 18, 2022K220228Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs
Shandong Blue Sail Health Technology Co., Ltd., CN
LZA
Mar 15, 2022K213121Disposable Nitrile Examination Glove
Jiangsu Cureguard Glove Co., Ltd., CN
LZA
Mar 10, 2022K213373Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Smart Glove Corporation Sdn. Bhd., MY
LZA
Mar 10, 2022K212148Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs
Ansell Healthcare Products, LLC
LZA
Mar 9, 2022K213851Disposable Medical Nitrile gloves
Guangdong Xingcan Brothers Medical Technology Co.,Ltd, CN
LZA
Mar 4, 2022K211808Medcare Powder-Free Blue Nitrile Patient Examination Gloves
Dongguan Grinvald Technology Co., Ltd., CN
LZA
Mar 4, 2022K210330Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
Wrp Asia Pacific Sdn. Bhd., MY
LZA
Feb 28, 2022K212833Disposable Nitrile Examination Gloves
Chifeng Huawei Medical Science&Technology Co., Ltd., CN
LZA
Feb 21, 2022K213548Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
Mercator Medical (Thailand), Ltd., TH
LZA

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