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510(k) Data Aggregation

    K Number
    K040841
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2004-07-08

    (98 days)

    Product Code
    LZA
    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

    Medline Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) are intended for medical purposes 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 (Tested for Use with Chemotherapy Drugs)

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details that would allow me to answer your request. The document is an FDA 510(k) clearance letter for "Powder-Free Blue Nitrile Examination Gloves," which primarily confirms substantial equivalence to a predicate device and outlines regulatory compliance. It does not include a technical evaluation or performance data.

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