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510(k) Data Aggregation

    K Number
    K222498
    Device Name
    Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
    Manufacturer
    Humanwell Healthcare Group Medical Supplies Co., Ltd.
    Date Cleared
    2022-10-26

    (69 days)

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

    Humanwell Healthcare Group Medical Supplies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Examination Glove (Nitrile) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    The Medical Examination Gloves (Nitrile) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in sizes extra-small, small, medium, large, extra-large packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.
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