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510(k) Data Aggregation

    K Number
    K211865
    Device Name
    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
    Date Cleared
    2021-12-20

    (187 days)

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

    Liao Ning Shangwei Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Vinyl Patient Examination Gloves, 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.
    Device Description
    The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile. The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.
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