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510(k) Data Aggregation

    K Number
    K183068
    Device Name
    Nitrile Glove Powder Free White
    Date Cleared
    2018-12-21

    (46 days)

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

    Haining Medical Products Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Date Cleared
    2018-11-15

    (62 days)

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

    Haining Medical Products Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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    K Number
    K152715
    Device Name
    HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
    Date Cleared
    2016-02-25

    (157 days)

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

    HAINING MEDICAL PRODUCTS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.
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