Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K091965
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED
    Date Cleared
    2009-11-24

    (146 days)

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

    PLATINUM GLOVE INDUSTRIES SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves, Black Powder Free Nitrile Examination Gloves, Blue, Grape Scented
    Ask a Question

    Ask a specific question about this device

    K Number
    K080165
    Device Name
    SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY)
    Date Cleared
    2008-05-14

    (112 days)

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

    PLATINUM GLOVE INDUSTRIES SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Smart Savers, Powder Free Nitrile Examination Gloves, Blue, White, Pink and Gray color
    Ask a Question

    Ask a specific question about this device

    K Number
    K051372
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR)
    Date Cleared
    2005-07-07

    (42 days)

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

    PLATINUM GLOVE INDUSTRIES SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves With Peppermint Scented (Blue Color)
    Ask a Question

    Ask a specific question about this device

    K Number
    K051317
    Device Name
    POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR
    Date Cleared
    2005-06-20

    (31 days)

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

    PLATINUM GLOVE INDUSTRIES SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Polymer Coated Powder Free Nitrile Examination Gloves, Blue, Green and White color.
    Ask a Question

    Ask a specific question about this device

    K Number
    K051318
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)
    Date Cleared
    2005-06-17

    (28 days)

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

    PLATINUM GLOVE INDUSTRIES SDN.BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves (White, Blue and Purple Color)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1