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510(k) Data Aggregation

    K Number
    K183068
    Device Name
    Nitrile Glove Powder Free White
    Manufacturer
    Haining Medical Products Co., Ltd.
    Date Cleared
    2018-12-21

    (46 days)

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

    Haining Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Glove Powder Free White is a disposable device intended purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is white. The proposed device is non-sterile.
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    K Number
    K182528
    Device Name
    Nitrile Glove Powder Free Black
    Manufacturer
    Haining Medical Products Co., Ltd.
    Date Cleared
    2018-11-15

    (62 days)

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

    Haining Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Glove Powder Free Black is a disposable device intended purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is black. The proposed device is non-sterile.
    Ask a Question

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