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510(k) Data Aggregation

    K Number
    K160675
    Device Name
    Powder free vinyl patient examination glove, colored (yellow)
    Manufacturer
    KAIXING PLASTIC PRODUCTS CO., LITD.
    Date Cleared
    2016-08-02

    (145 days)

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

    KAIXING PLASTIC PRODUCTS CO., LITD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder free vinyl patient examination glove, colored (yellow) is a non-sterile, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder free vinyl patient examination glove, colored (yellow) are patient examination gloves available in S, M, L, XL. They are provided non-sterile and meet the entire requirement of ASTM standard D5250-06(reapproved), except for sterility requirements.
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