BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇻🇳 Vietnam

    Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs

    K Number: K190403 · Decision Sep 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    1158
    Applicant Total
    4
    Review Days
    199

    Basic Information

    Device Name
    Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
    K Number
    K190403
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ever Global (Vietnam) Enterprise Corporation
    Date Received
    February 19, 2019
    Decision Date
    September 6, 2019
    Product Code
    LZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZA Polymer Patient Examination Glove

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    Other Clearances by Ever Global (Vietnam) Enterprise Corporation

    K Number Device Name
    K244034 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
    K221980 Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
    K220992 Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple