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510(k) Data Aggregation

    K Number
    K152818
    Device Name
    Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves
    Manufacturer
    Ideal Plastic Co., Ltd.
    Date Cleared
    2016-05-26

    (241 days)

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

    Ideal Plastic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder-Free Yellow Vinyl Patient Examination Gloves 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
    Powder-Free Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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