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510(k) Data Aggregation

    K Number
    K971356

    Validate with FDA (Live)

    Device Name
    POWDER FREE SYNTHETIC EXAMINATION GLOVES
    Manufacturer
    ARISTA LATINDO INDUSTRIAL, LTD. P.T.
    Date Cleared
    1997-09-05

    (147 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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

    Powder Free Blue Nitrile Examination Gloves

    AI/ML Overview

    The provided text is a letter from the FDA regarding the clearance of "Powder Free Nitrile Examination Gloves." It does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria. The letter primarily addresses the substantial equivalence determination for regulatory purposes. Therefore, I cannot extract the requested information from the given text.

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