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

    BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES

    K Number: K081971 · Decision Dec 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    78
    Applicant Total
    3
    Review Days
    166

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    Basic Information

    Device Name
    BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES
    K Number
    K081971
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nitritex (M) Sdn. Bhd.
    Date Received
    July 10, 2008
    Decision Date
    December 23, 2008
    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 Nitritex (M) Sdn. Bhd.

    K Number Device Name
    K081970 BIOCLEAN CHEMO SHIELD
    K081972 BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES