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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
Aug 24, 2021K211515Nitrile Examination Gloves
Beijing Reagent Latex Products Co., Ltd., CN
LZA
Aug 24, 2021K210897Disposable Nitrile Examination Gloves
Shandong DS Safety Technology Co., Ltd., CN
LZA
Aug 20, 2021K211699Nitrile Exam Gloves, Powder Free, Blue
Hengchang (Dongying) Medical Technology Co., Ltd., CN
LZA
Aug 20, 2021K203622Medical Gloves
Beijing Biosis Healing Biolog Ical Technology Co., Ltd., CN
LZA
Aug 20, 2021K201857Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
Careplus (M) Sdn Bhd, MY
LZA
Aug 19, 2021K211319Purism Non-Sterile Powder Free Nitrile Examination Gloves
Dezhou Purism Medical Technology Co., Ltd., CN
LZA
Aug 17, 2021K211708Disposable Medical Nitrile Gloves
Jiangsu Health-Peace Medical Technology Co., Ltd., CN
LZA
Aug 16, 2021K203236Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
Rhino Health, Inc.
LZA
Aug 13, 2021K211860Powder Free Nitrile Patient Examination Gloves, Blue Color
Anhui Powerguard Technology Co., Ltd., CN
LZA
Aug 11, 2021K202536Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherap
Yty Industry (Manjung) Sdn Bhd, MY
LZA
Aug 10, 2021K210730Nitrile Patient Examination Glove
American Performance Polymers, LLC
LZA
Aug 9, 2021K211540Edma Synthetic Nitrile Examination Gloves
Edma Group, LLC
LZA
Aug 6, 2021K210725Nitrile Patient Examination Glove
Pingan Medical Products Co., Ltd., CN
LZA
Aug 5, 2021K211608Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
Jiangsu Cureguard Glove Co., Ltd., CN
LZA
Aug 5, 2021K211434Nitrile Patient Examination Gloves
Zhangjiagang Huayuan Protective Equipment Co., Ltd., CN
LZA
Aug 5, 2021K211075Disposable Medical Nitrile Examination Gloves (Non-Sterile)
Jiangsu Cherish Medical Technology Co., Ltd., CN
LZA
Aug 4, 2021K211714Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
Hengchang (Dongying) Medical Technology Co., Ltd., CN
LZA
Aug 1, 2021K211182H2H Powder Free Examination Blue Glove
Ntl Innovation Co., Ltd., TH
LZA
Jul 30, 2021K211264Disposable Nitrile Examination Gloves
Shenzhen Shiqiao Science and Technology Co., Ltd., CN
LZA
Jul 30, 2021K210691Disposable Nitrile Medical Examination Glove
Jiangsu Cureguard Glove Co., Ltd., CN
LZA
Jul 29, 2021K211341Blue Nitrile Exam Gloves
Jiangxi Surefine Medical Co., Ltd., CN
LZA
Jul 29, 2021K211131Disposable Nitrile Medical Examination Glove
Siyang Threeguard Medical Supplies Co., Ltd., CN
LZA
Jul 28, 2021K211455Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
Shen Wei USA, Inc.
LZA
Jul 23, 2021K211012Nitrile Patient Examination Gloves
Huayuan Medical Technology(Shangqiu) Co., Ltd., CN
LZA
Jul 22, 2021K211220Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue
Guangdong Kingfa Sci. & Tech.Co., Ltd., CN
LZA
Jul 21, 2021K210686Nitrile Patient Examination Glove
Yunnan Huazhiyuan Medical Technology Co., Ltd., CN
LZA
Jul 20, 2021K210684Disposable Nitrile Medical Examination Glove
Jiangsu Cureguard Glove Co., Ltd., CN
LZA
Jul 15, 2021K211547Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Edma Group, LLC
LZA
Jul 12, 2021K210776Nitrile Examination Gloves
5r Med Instruments (Chengdu) Co., Ltd., CN
LZA
Jul 12, 2021K210723Nitrile Patient Examination Glove
Jiangxi Zhonghong Pulin Medical Products Co., Ltd., CN
LZA
Jul 10, 2021K210578Medical Nitrile Examination Gloves (Power free, Blue)
Jiangxi Hongda Medical Equipment Group , Ltd., CN
LZA
Jun 28, 2021K210775White Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx Sdn Bhd, MY
LZA
Jun 28, 2021K210587Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx Sdn Bhd, MY
LZA
Jun 25, 2021K211252Nitrile Glove
Jiangsu Dihong Industry and Trade Co., Ltd., CN
LZA
Jun 24, 2021K201428Powder Free Black Nitrile Examination Glove
Vietglove Corporation, VN
LZA
Jun 21, 2021K210375Powder Free Blue Nitrile Examination Glove
Duramitt Sdn Bhd, MY
LZA
Jun 21, 2021K202085Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
Shen Wei USA, Inc.
LZA
Jun 16, 2021K211310AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
Megine Industries Sdn Bhd, MY
LZA
Jun 13, 2021K210401Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, M
Ansell Healthcare Products, LLC
LZA
Jun 4, 2021K211028Nitrile Patient Examination Gloves
Huayuan Medical Technology(Shangqiu) Co., Ltd., CN
LZA
May 13, 2021K210369Powder Free Nitrile Examination Glove
Pastel Glove Sdn Bhd, MY
LZA
May 7, 2021K210755Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)
Meditech Gloves Sdn Bhd, MY
LZA
May 7, 2021K210366Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx Sdn Bhd, MY
LZA
May 7, 2021K203036Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)
Central Medicare Sdn Bhd, MY
LZA
Apr 29, 2021K210944Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
Harbour Health, LLC
LZA
Apr 28, 2021K203436Disposable Nitrile Examination Gloves
Shandong Zhushi Pharmaceutical Group Co., Ltd., CN
LZA
Apr 26, 2021K203512Powder Free Blue Nitrile Examination Glove
Vip Glove Sdn Bhd, MY
LZA
Apr 21, 2021K210145Nitrile Glove Powder Free Blue
Changzhou Universal Medical Equipment Co., Ltd., CN
LZA
Apr 20, 2021K203805Disposable Nitrile Examination Gloves
Jiangsu Yanfang Medical Technology Co., Ltd., CN
LZA
Apr 16, 2021K210276Disposable Nitrile Gloves
Fujian Ercon Medical Management Co., Ltd., CN
LZA

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