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

    POWDER FREE LATEX EXAMINATION GLOVES

    K Number: K071322 · Decision Jul 13, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    4
    Review Days
    64

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    Basic Information

    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES
    K Number
    K071322
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Quality Gallant Sdn. Bhd.
    Date Received
    May 10, 2007
    Decision Date
    July 13, 2007
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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    Other Clearances by Quality Gallant Sdn. Bhd.

    K Number Device Name
    K092874 POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES
    K081592 POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
    K071323 POWDERED LATEX EXAMINATION GLOVES