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510(k) Data Aggregation

    K Number
    K120110
    Device Name
    ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
    Manufacturer
    PROFIT POINT MANUFACTURING SDN BHD
    Date Cleared
    2012-10-04

    (265 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROFIT POINT MANUFACTURING SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Nitrile powder free examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)
    Device Description
    ELEGANT Nitrile Powder Free Examination Gloves
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    K Number
    K101760
    Device Name
    ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES
    Manufacturer
    PROFIT POINT MANUFACTURING SDN BHD
    Date Cleared
    2010-10-06

    (105 days)

    Product Code
    LZA, JDI, LWJ, LZO
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROFIT POINT MANUFACTURING SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Nitrile powder free examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (21 CFR 880.6250)
    Device Description
    Model 1: White Nitrile, Powder Free Examination Gloves Model 2: Blue Nitrile, Powder Free Examination Gloves Model 3: Pink Nitrile, Powder Free Examination Gloves
    Ask a Question

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