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510(k) Data Aggregation

    K Number
    K984147
    Device Name
    LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES
    Manufacturer
    LOVYTEX SDN BHD
    Date Cleared
    1999-01-20

    (62 days)

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

    LOVYTEX SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient.
    Device Description
    Powder-free Polymer Coated Latex Examination Gloves with protein label claim 50 micro-grams per gram
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    K Number
    K981179
    Device Name
    LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    LOVYTEX SDN BHD
    Date Cleared
    1998-05-15

    (44 days)

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

    LOVYTEX SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient.
    Device Description
    Powder-free Nitrile Examination Gloves
    Ask a Question
    K Number
    K980618
    Device Name
    LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES
    Manufacturer
    LOVYTEX SDN BHD
    Date Cleared
    1998-03-13

    (23 days)

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

    LOVYTEX SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between heathcare personnel and the patient.
    Device Description
    Powder-free Latex Examination Gloves
    Ask a Question

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