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

    Disposable Powder Free Vinyl Examination Gloves, Beige/Clear

    K Number: K221980 · Decision Feb 6, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    795
    Applicant Total
    4
    Review Days
    216

    Basic Information

    Device Name
    Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
    K Number
    K221980
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ever Global (Vietnam) Enterprise Corporation
    Date Received
    July 5, 2022
    Decision Date
    February 6, 2023
    Product Code
    LYZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYZ Vinyl Patient Examination Glove

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