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

    ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET

    K Number: K120110 · Decision Oct 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    2
    Review Days
    265

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    Basic Information

    Device Name
    ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
    K Number
    K120110
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Profit Point Manufacturing Sdn Bhd
    Date Received
    January 13, 2012
    Decision Date
    October 4, 2012
    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 Profit Point Manufacturing Sdn Bhd

    K Number Device Name
    K101760 ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES