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510(k) Data Aggregation

    K Number
    K043478
    Device Name
    POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
    Date Cleared
    2005-03-09

    (83 days)

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

    SHIJAIZHUANG BRILLIANT OCEAN 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 hand to prevent contamination between patient and examiner.
    Device Description
    Powdered Yellow Synthetic Vinyl Patient Examination Gloves
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    K Number
    K043499
    Device Name
    POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
    Date Cleared
    2005-02-04

    (49 days)

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

    SHIJAIZHUANG BRILLIANT OCEAN 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 examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Yellow Synthetic Vinyl Patient Examination Gloves
    Ask a Question

    Ask a specific question about this device

    K Number
    K043159
    Device Name
    POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
    Date Cleared
    2004-12-20

    (35 days)

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

    SHIJAIZHUANG BRILLIANT OCEAN 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 examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Clear Synthetic Vinyl Examination Gloves
    Ask a Question

    Ask a specific question about this device

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