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510(k) Data Aggregation

    K Number
    K031913
    Device Name
    VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
    Manufacturer
    ARISTA LATINDO INDUSTRIAL, LTD. P.T.
    Date Cleared
    2003-07-09

    (19 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

    Device Description

    Vinyl Examination Gloves, Powder Free, Violet Color

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth for a medical device. The text is a 510(k) premarket notification letter from the FDA to a medical glove manufacturer, confirming the substantial equivalence of their "Vinyl Examination Gloves, Powder Free, Violet Color" to a legally marketed predicate device.

    The document discusses regulatory compliance for patient examination gloves but does not contain any scientific study data, performance metrics, or details about how the device's efficacy or safety was evaluated using acceptance criteria.

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