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Panels › General Hospital › Product code LZA · Class 1

Polymer Patient Examination Glove

Regulation 880.6250

16510(k)s in 12 months (1,181 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
May 28, 2024K240629Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Xingyu Medical Tech Co., Ltd., CN
LZA
May 13, 2024K232614Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, an
Sri Trang Gloves (Thailand) Public Company Limited, TH
LZA
Apr 22, 2024K232319Black Pearl Nitrile Examination Glove
Ug Global Resources Sdn. Bhd., MY
LZA
Apr 8, 2024K240021Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fenta
Yue Kang Anhui Medical Products Co., Ltd., CN
LZA
Apr 4, 2024K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); P
Hebei Titans Hongsen Medical Technology Co., Ltd., CN
LZA
Apr 2, 2024K240080Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Syntex Healthcare Products Co., Ltd., CN
LZA
Apr 1, 2024K233990Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
Shandong Xingyu Gloves Co., Ltd., CN
LZA
Mar 27, 2024K234097Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentany
Ever Growth (Vietnam) Corporation Limited, VN
LZA
Mar 22, 2024K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fen
O&M Halyard, Inc.
LZA
Mar 20, 2024K232654Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
Nephron Nitrile, LLC
LZA
Mar 1, 2024K231365Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fent
Anhui Intco Medical Products Co., Ltd., CN
LZA
Feb 29, 2024K240051Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Othe
Lingshi Hongruida Health Protection Technology Co., Ltd., CN
LZA
Feb 26, 2024K233560Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs,
Eco Medi Glove Sdn. Bhd., MY
LZA
Feb 13, 2024K233740Black Nitrile Powder Free Patient Examination Glove, Non Sterile
W.A. Rubbermate Co., Ltd., TH
LZA
Feb 9, 2024K240072Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
Luliang Hongruida Health Protection Technology Co., Ltd., CN
LZA
Feb 7, 2024K232764Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Eco Medi Glove Sdn. Bhd., MY
LZA
Jan 26, 2024K233598Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl
Anhui Intco Medical Products Co., Ltd., CN
LZA
Jan 16, 2024K233970Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
Nephron Nitrile, LLC
LZA
Jan 12, 2024K233520Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Anhui Powerguard Technology Co., Ltd., CN
LZA
Dec 28, 2023K233405Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim
Eco Medi Glove Sdn. Bhd., MY
LZA
Dec 15, 2023K233182Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
Zibo Kaiyue Mould Technology Co., Ltd., CN
LZA
Dec 6, 2023K233042Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Shandong Intco Medical Products Co, Ltd., CN
LZA
Nov 28, 2023K232252Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Pow
Dehai (Shandong) Medical Gloves, Co., Ltd., CN
LZA
Nov 21, 2023K232576Medical Nitrile Examination Gloves
Jiangsu Complete Sincerity Medical New Materials Co., Ltd., CN
LZA
Nov 17, 2023K232538DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
Wrp Asia Pacific Sdn. Bhd., MY
LZA
Nov 14, 2023K232461Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Ci
Kossan International Sdn Bhd, MY
LZA
Nov 3, 2023K232266Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fe
Better Care Plastic Technology Co., Ltd., CN
LZA
Oct 30, 2023K231029Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
Zhonghong Pulin Medical Products Co., Ltd., CN
LZA
Oct 26, 2023K230662Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs
Zhonghong Pulin Medical Products Co., Ltd., CN
LZA
Oct 20, 2023K232550Nitrile Examination Gloves, Dual Color Black-Blue
Shanxi Hongjin Plastic Technology Co., Ltd., CN
LZA
Oct 11, 2023K232070Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
Better Care Plastic Technology Co., Ltd., CN
LZA
Oct 6, 2023K230777Patient Examination Gloves
3A Glove Sdn. Bhd., MY
LZA
Oct 4, 2023K231567Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select
Better Care Plastic Technology Co., Ltd., CN
LZA
Oct 2, 2023K232064Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
Isikel Manufacturing, LLC
LZA
Oct 2, 2023K230681Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fe
Central Medicare Sdn Bhd, MY
LZA
Sep 29, 2023K230847Chemotherapy Gloves
3A Glove Sdn. Bhd., MY
LZA
Sep 21, 2023K223214Powder-Free Nitrile Examination Gloves
Global Protection Corp.
LZA
Sep 8, 2023K231643Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Syntex Healthcare Products Co., Ltd., CN
LZA
Aug 31, 2023K232353Powder Free Nitrile Examination Gloves (Black)
Shanxi Hongjin Plastic Technology Co., Ltd., CN
LZA
Aug 28, 2023K231435KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate,
Kimberly-Clark Corporation
LZA
Aug 24, 2023K222103Nitrile Patient Examination Gloves, Powder Free, Pink Color
Shandong Yinghng Medical Products Co., Ltd., CN
LZA
Aug 16, 2023K230314Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
New Era Medicare Sdn. Bhd., MY
LZA
Aug 11, 2023K231439Powder Free White, Black, and Purple Nitrile Examination Glove
S&S Glove Corporation, VN
LZA
Aug 11, 2023K231408Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
Shandong Intco Medical Products Co, Ltd., CN
LZA
Aug 9, 2023K232039Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Grand Work Plastic Products Co., Ltd., CN
LZA
Aug 8, 2023K232008Disposable Medical Examination Nitrile Gloves
Raxwell Industrial, LLC
LZA
Aug 7, 2023K223713Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Better Care Plastic Technology Co., Ltd., CN
LZA
Jul 24, 2023K223752Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cycl
Central Medicare Sdn Bhd, MY
LZA
Jul 21, 2023K231021KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simul
Kimberly-Clark Corporation
LZA
Jul 20, 2023K230875Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fe
Central Medicare Sdn Bhd, MY
LZA

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