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510(k) Data Aggregation

    K Number
    K990751
    Device Name
    SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES
    Manufacturer
    SOUTHLAND PRODUCTS CO., LTD.
    Date Cleared
    1999-03-23

    (15 days)

    Product Code
    LYY
    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 gloves is a disposable device intended for medical purpose that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.

    Device Description

    Powderfree( Polymer coated ) patient latex examination gloves

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Southland Powder-Free (Polymer-Coated) Latex Examination Gloves." This document does not contain any information about acceptance criteria or studies that prove the device meets acceptance criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It mentions the product code (LYY) and regulatory class (I), and states the indications for use.

    Therefore, I cannot provide the requested information.

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