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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
Nov 2, 2022K211816Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citr
Brightway Holdings Sdn. Bhd., MY
LZA
Oct 26, 2022K223235Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
Pt. Sintong Unigolden Glove, ID
LZA
Oct 26, 2022K222498Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
Humanwell Healthcare Group Medical Supplies Co., Ltd., CN
LZA
Oct 25, 2022K221169JR MEDIC Nitrile Examination Gloves Powder Free- Black
Jr Engineering & Medical Technologies (M) Sdn. Bhd., MY
LZA
Oct 21, 2022K222349JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
Jr Engineering & Medical Technologies (M) Sdn. Bhd., MY
LZA
Oct 18, 2022K222721Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited, CN
LZA
Oct 18, 2022K222298Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fe
Onetexx Sdn Bhd, MY
LZA
Oct 17, 2022K222074Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves
Zibo Langu New Material Technology Co., Ltd., CN
LZA
Oct 7, 2022K222714Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue
Guangdong Kingfa Sci. & Tech.Co., Ltd., CN
LZA
Oct 1, 2022K222937Disposable Nitrile Examination Glove
Jiangsu Cureguard Glove Co., Ltd., CN
LZA
Sep 30, 2022K221378Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
Tec Gloves Industry (M) Sdn.Bhd., MY
LZA
Sep 24, 2022K222342Betel Gloves Nitrile Examination Glove Powder Free
Betel Care Sdn. Bhd., MY
LZA
Sep 24, 2022K222294Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fen
Onetexx Sdn Bhd, MY
LZA
Sep 24, 2022K221887Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color
Guangdong Kingfa Sci. & Tech.Co., Ltd., CN
LZA
Sep 24, 2022K212751Powder Free Nitrile Examination Glove
Dainam Glove Joint Stock Company, VN
LZA
Sep 20, 2022K222642Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug)
Inner Mongolia Cureguard Medical Technology Co., Ltd., CN
LZA
Sep 20, 2022K214056Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)
Mezorrison Medical Technology (Dongying) Co., Ltd., CN
LZA
Sep 15, 2022K220697Nitrile Patient Examination Gloves, Powder Free
Lalan Rubbers (Pvt), Ltd., LK
LZA
Sep 9, 2022K220859Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
Careglove Global Sdn. Bhd., MY
LZA
Aug 30, 2022K221164Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
Hong Seng Gloves Sdn Bhd, MY
LZA
Aug 25, 2022K221143Nitrile Exam Gloves (Blue, Black)
Hebei Astro Medical Supply Co., Ltd., CN
LZA
Aug 16, 2022K213937Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fent
O&M Halyard, Inc.
LZA
Aug 6, 2022K213934Pro Guard Nitrile Powder Free Examination Glove
Medical Glove Co., Ltd., TH
LZA
Aug 5, 2022K221350Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Rubberex Alliance Products Sdn Bhd, MY
LZA
Aug 5, 2022K213993Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
Careglove Global Sdn. Bhd., MY
LZA
Aug 1, 2022K220237Disposable Medical Nitrile Examination Gloves
Fujian Jixiang Medical Technology Co.,Ltd, CN
LZA
Aug 1, 2022K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast
O&M Halyard, Inc.
LZA
Jul 30, 2022K221773Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simula
Onetexx Sdn Bhd, MY
LZA
Jul 27, 2022K221271Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
Shandong Maida Medical Technology Co., Ltd., CN
LZA
Jul 27, 2022K221269Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Better Care Plastic Technology Co., Ltd., CN
LZA
Jul 23, 2022K221877Powder-Free Nitrile Examination Glove, Non-Sterile
Goodgloves Industries Sdn Bhd, MY
LZA
Jul 19, 2022K220943Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
Eco Medi Glove Sdn. Bhd., MY
LZA
Jul 16, 2022K221229Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves
Zibo Blue Sail Health Technology Co., Ltd., CN
LZA
Jul 12, 2022K221454Disposable Medical Nitrile Examination Gloves - Non Sterile
Guangzhou Kangling Biotechnology Co., Ltd., CN
LZA
Jul 12, 2022K221108Nitrile Medical Examination Gloves
Anhui Fulewei Electronic Technology Co.,Ltd, CN
LZA
Jul 12, 2022K213574Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
Grand Work Plastic Products Co., Ltd., CN
LZA
Jul 8, 2022K220825Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
American Nitrile Operations, LLC
LZA
Jul 8, 2022K220284Powder Free Nitrile Examination Gloves (Blue)
Kgm Gloves Sdn. Bhd., MY
LZA
Jun 29, 2022K220834Powder Free Nitrile Examination Glove
Daxwell, LLC
LZA
Jun 22, 2022K221192Disposable Nitrile Powder-Free Examination Gloves
Shandong Maida Medical Technology Co., Ltd., CN
LZA
Jun 22, 2022K213739Nitrile Examination Gloves
Hangzhou Runheng Medical Co., Ltd., CN
LZA
Jun 17, 2022K220431Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
One Glove Industrial Sdn Bhd, MY
LZA
Jun 16, 2022K2212261st Glove Blue Nitrile Examination Gloves Powder Free
Koove Iot Pvt. , Ltd., IN
LZA
Jun 16, 2022K221186TC Gloves
Thanh Cong Pharmaceutical and Trading Company Limited, VN
LZA
Jun 7, 2022K220693Zoupure Nitrile Powder Free Examination glove
Thai Rayong Product Glove Zoupure Co., Ltd., TH
LZA
Jun 6, 2022K213448Powder Free Nitrile Gloves
St Future International Limited, CN
LZA
Jun 3, 2022K220672Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
Riverstone Resources Sdn Bhd, MY
LZA
Jun 2, 2022K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.
LZA
Jun 2, 2022K220541PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.
LZA
Jun 1, 2022K220488Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd., CN
LZA

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