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

    POWDER-FREE NITRILE GLOVES, BLACK

    K Number: K100369 · Decision May 20, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    7
    Review Days
    97

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    Basic Information

    Device Name
    POWDER-FREE NITRILE GLOVES, BLACK
    K Number
    K100369
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hl Rubber Industries Sdn Bhd
    Date Received
    February 12, 2010
    Decision Date
    May 20, 2010
    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 Hl Rubber Industries Sdn Bhd

    K Number Device Name
    K220545 Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
    K141021 POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
    K140316 EXAMINATION GLOVES
    K130038 POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
    K063522 POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)
    K063524 POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)