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

    ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE

    K Number: K063777 · Decision Feb 23, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    63

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    Basic Information

    Device Name
    ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
    K Number
    K063777
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bright Element Sdn Bhd
    Date Received
    December 22, 2006
    Decision Date
    February 23, 2007
    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 Bright Element Sdn Bhd

    K Number Device Name
    K063776 ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES
    K061074 ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
    K061078 BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES