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510(k) Data Aggregation

    K Number
    K211673
    Device Name
    Disposable Medical Nitrile Gloves
    Manufacturer
    Changzhou Yihua Sanitation Material Co., Ltd
    Date Cleared
    2021-09-01

    (92 days)

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

    Changzhou Yihua Sanitation Material Co., Ltd

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