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510(k) Data Aggregation

    K Number
    K111300
    Device Name
    SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
    Date Cleared
    2011-08-12

    (95 days)

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

    PT. MAHAKARYA INTI BUANA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Green, Orange, Violet and White Nitrile examination gloves, Powder Free, Non - Sterile are disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder Free Green, Orange, Violet and White Nitrile Examination Gloves, Non Sterile is a disposable device intended for medical purposes that is worn on the examiner's to prevent contamination between patient and examiner.
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    K Number
    K062313
    Device Name
    SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
    Date Cleared
    2006-11-30

    (114 days)

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

    PT. MAHAKARYA INTI BUANA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    High Risk Latex Examination Gloves, Powder Free Non Sterile is a disposable device and made of natural rubber latex for medical purpose that is worn on the examiner's hand or finger to prevent conta mination between patient and examiner.
    Device Description
    HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE NON STERILE is a disposable device and made of natural rubber latex.
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    K Number
    K061233
    Device Name
    SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
    Date Cleared
    2006-11-03

    (185 days)

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

    PT. MAHAKARYA INTI BUANA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber Intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
    Device Description
    Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber
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    K Number
    K053366
    Device Name
    NITRILE EXAMINATION GLOVES, POWDERED, NON STERILE
    Date Cleared
    2006-03-30

    (115 days)

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

    PT. MAHAKARYA INTI BUANA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powdered Nitrile Examination Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
    Device Description
    The Powdered Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Test.
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    K Number
    K053657
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, NON-STERILE
    Date Cleared
    2006-02-13

    (70 days)

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

    PT. MAHAKARYA INTI BUANA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Nitrile Examination. Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands of finger to prevent contamination between patient and examiner.
    Device Description
    The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Icct.
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    K Number
    K052273
    Device Name
    POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
    Date Cleared
    2005-09-30

    (39 days)

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

    PT. MAHAKARYA INTI BUANA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.
    Device Description
    The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
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