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510(k) Data Aggregation

    K Number
    K043149

    Validate with FDA (Live)

    Device Name
    FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)
    Manufacturer
    FIRSTLINE, LLC.
    Date Cleared
    2005-05-25

    (191 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    18 - 65
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FirstLine Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free – Steel Blue Color) is a disposable patient examination glove that 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.

    Device Description

    Double Polymer Coated, Nitrile Examination Gloves (Powder-Free, Non-Sterile, Steel-Blue Color)

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for Double Polymer Coated, Nitrile Examination Gloves. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices, but it does not provide performance data or details of a study.

    Therefore, I cannot provide the requested information based on the provided text.

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