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510(k) Data Aggregation

    K Number
    K212929
    Device Name
    Nitrile Examination Gloves
    Manufacturer
    Watchtower PPE Supplies Inc.
    Date Cleared
    2022-04-09

    (207 days)

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

    Watchtower PPE Supplies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.
    Device Description
    The proposed Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, Not made with natural rubber latex and is made of nitrile (Butyronitrile latex) . It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile. The device is provided in 4 sizes, from small to extra-large.
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