BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇾 Malaysia

    Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile

    K Number: K220429 · Decision May 13, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    87

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    Basic Information

    Device Name
    Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
    K Number
    K220429
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    One Glove Industrial Sdn Bhd
    Date Received
    February 15, 2022
    Decision Date
    May 13, 2022
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by One Glove Industrial Sdn Bhd

    K Number Device Name
    K220431 Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
    K220428 Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
    K220427 White Nitrile Powder-Free Patient Examination Glove, Non Sterile