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510(k) Data Aggregation

    K Number
    K211236
    Device Name
    Disposable Vinyl Examination Gloves
    Date Cleared
    2021-09-27

    (154 days)

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

    Tangshan Hongyun Healthcare Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Vinyl Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
    Device Description
    Disposable Vinyl Examination Gloves
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