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510(k) Data Aggregation

    K Number
    K974442
    Device Name
    PRE-POWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    P.T. LATEXINDO TOBAPERKASA
    Date Cleared
    1998-01-05

    (41 days)

    Product Code
    LZY
    Regulation Number
    888.3360
    Why did this record match?
    Applicant Name (Manufacturer) :

    P.T. LATEXINDO TOBAPERKASA

    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 healthcare personnel and patient.
    Device Description
    Pre-powdered Nitrile Examination Gloves
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    K Number
    K974443
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED
    Manufacturer
    P.T. LATEXINDO TOBAPERKASA
    Date Cleared
    1998-01-05

    (41 days)

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

    P.T. LATEXINDO TOBAPERKASA

    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 healthcare personnel and patient.
    Device Description
    Powder Free Nitrile Examination Gloves (Polymer Coated)
    Ask a Question
    K Number
    K972539
    Device Name
    Hi Coat Powder Free Latex Patient Examination Gloves
    Manufacturer
    P.T. LATEXINDO TOBAPERKASA
    Date Cleared
    1997-11-18

    (133 days)

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

    P.T. LATEXINDO TOBAPERKASA

    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 healthcare personnel and patient.
    Device Description
    Powder Free Latex Patient Examination Gloves
    Ask a Question

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