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

    Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs

    K Number: K220545 · Decision May 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
    K Number
    K220545
    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 25, 2022
    Decision Date
    May 26, 2022
    Product Code
    LZC
    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
    LZC Medical Glove, Specialty

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    Other Clearances by Hl Rubber Industries Sdn Bhd

    K Number Device Name
    K141021 POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
    K140316 EXAMINATION GLOVES
    K130038 POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
    K100369 POWDER-FREE NITRILE GLOVES, BLACK
    K063522 POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)
    K063524 POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)