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510(k) Data Aggregation

    K Number
    K112796
    Device Name
    SURGICAL GOWN (EO STERILIZED)
    Manufacturer
    COBES INDUSTRIES CO., LTD.
    Date Cleared
    2013-09-12

    (717 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cobes Sterile Disposable Surgical Gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

    Device Description

    Cobes Sterile Disposable Surgical Gown Model: G200XB Series (G2001B, G2002B and G2003B) G200XG Series (G2001G, G2002G and G2003G)

    Model SeriesModelMaterialSize
    G200XB Series (Blue)G2001BSSMMSL
    G2002BSSMMSXL
    G2003BSSMMSXXL
    G200XG Series (Green)G2001GSMMSL
    G2002GSMMSXL
    G2003GSMMSXXL
    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or any of the other specific points you've requested regarding a medical device's performance evaluation.

    The document is a 510(k) premarket notification letter from the FDA to a company called Cobes Industries Company, Limited, regarding their "Cobes Sterile Disposable Surgical Gown." It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. The enclosure provides the indicated uses and model details of the surgical gowns.

    Therefore, I cannot extract the information needed to answer your request based on this document.

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