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

    Disposable Powder Free Vinyl Exam Glove, Clear/Yellow

    K Number: K170575 · Decision May 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    798
    Applicant Total
    3
    Review Days
    78

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    Basic Information

    Device Name
    Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
    K Number
    K170575
    Device Class
    FDA class 1
    Clearance Type
    Abbreviated
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ever Global (Vietnam) Enterprise Corp
    Date Received
    February 27, 2017
    Decision Date
    May 16, 2017
    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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    Other Clearances by Ever Global (Vietnam) Enterprise Corp

    K Number Device Name
    K193555 Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
    K171422 Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color