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510(k) Data Aggregation

    K Number
    K220693
    Device Name
    Zoupure Nitrile Powder Free Examination glove
    Date Cleared
    2022-06-07

    (90 days)

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

    Thai Rayong Product Glove Zoupure Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Zoupure Nitrile Powder Free Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
    Device Description
    Zoupure Nitrile Powder Free Examination Glove
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