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510(k) Data Aggregation

    K Number
    K091772
    Device Name
    POWDER-FREE VINYL EXAM GLOVES
    Date Cleared
    2010-04-08

    (296 days)

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

    SHIJIAZHUANG HUIJINGYUAN PLASTIC CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    POWDER-FREE VINYL EXAM GLOVES
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    K Number
    K091770
    Device Name
    VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR
    Date Cleared
    2010-04-06

    (294 days)

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

    SHIJIAZHUANG HUIJINGYUAN PLASTIC CO, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purpose that A partient chanination goss hands or finger to prevent contamination between patient and examiner.
    Device Description
    VINYL PATIENT EXAM GLOVES PRE-POWDERED, CLEAR
    Ask a Question

    Ask a specific question about this device

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