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510(k) Data Aggregation

    K Number
    K122396
    Device Name
    POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
    Date Cleared
    2013-01-31

    (177 days)

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

    WEALTH ON (JIANGSU) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The powdered vinyl patient examination glove, clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The powder is made from cornstarch. It is color free and is sold as non sterile.
    Device Description
    Powdered vinyl patient examination gloves, clear (non-colored) are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. The powder is made from cornstarch. The gloves are color free.
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    K Number
    K120584
    Device Name
    POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES
    Date Cleared
    2012-07-10

    (134 days)

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

    WEALTH ON (JIANGSU) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The powder free light yellow stretch vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It has light yellow color and is sold as non sterile.
    Device Description
    Powder free light-yellow stretch vinyl patient examination gloves are made of polyvinyl chloride, and are non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements. They have light yellow color.
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    K Number
    K110219
    Device Name
    POWDER FREE VINYL PATIENT EXAMINATION GLOVES
    Date Cleared
    2011-04-19

    (84 days)

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

    WEALTH ON (JIANGSU) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The powder free vinyl patient examination glove, Clear (non-colored) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.
    Device Description
    Powder free vinyl patient examination gloves, clear (non-colored), non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements.
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