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510(k) Data Aggregation

    K Number
    K212363
    Device Name
    Disposable Medical Nitrile Examination Gloves
    Manufacturer
    Lanhuo Medical Technology (Jiangsu) Co.,Ltd
    Date Cleared
    2021-10-26

    (88 days)

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

    Lanhuo Medical Technology (Jiangsu) Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The disposable medical nitrile examination gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
    Device Description
    The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
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