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510(k) Data Aggregation

    K Number
    K090464
    Device Name
    BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
    Date Cleared
    2009-04-23

    (59 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
    A powder-free patient 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.
    Device Description
    Powder-free Black 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
    K063581
    Device Name
    SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
    Date Cleared
    2007-03-15

    (105 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
    Senstouch High Risk Blue Latex Examination Gloves Powdeced, Non-Starile is a disposable device and mad of natural cubber latex for medical purpose that worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Senstouch High Risk Blue Latex Examination Gloves, Powdered, Non-Sterile is a disposable device and made of natural rubber latex.
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    K Number
    K053305
    Device Name
    SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
    Date Cleared
    2006-06-02

    (186 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
    A Powdered Latex Examination Glove Non Sterile is a disposable device made of natural rubber latex that bears powder to facilitate donning and is intended to be worn on the hand of finger(s) for a medical purpose to provide a barrier againts potentially insfectious material and other contaminations.
    Device Description
    The Powdered Latex Examination Gloves, Non Sterile (Contains 200 micrograms or less of Total Water Extractable Protein per dm4) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
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