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510(k) Data Aggregation

    K Number
    K050450
    Device Name
    SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
    Date Cleared
    2005-04-04

    (41 days)

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

    **ZIBO BLUE INTCO PLASTIC **& RUBBER PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
    Device Description
    Patient Vinyl Examination Gloves, Powderfree, Non-Sterile
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    K Number
    K050455
    Device Name
    SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
    Date Cleared
    2005-03-29

    (35 days)

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

    **ZIBO BLUE INTCO PLASTIC **& RUBBER PRODUCTS CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between paties: and examiner (21CFR 880.6250)
    Device Description
    Patient Vinyl Examination Gloves, Powdered
    Ask a Question

    Ask a specific question about this device

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