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510(k) Data Aggregation

    K Number
    K012240
    Device Name
    MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE
    Manufacturer
    MERCAN AB
    Date Cleared
    2001-10-15

    (90 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

    The Sewing Source O.R./Surgeon's Gowns, based on the both the Maxima ESD and Mertex-Plus E3333-R materials, are reusable gowns that are intended to be 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. For manufacturing, processing, or repackaging, these gowns must be reprocessed and packaged.

    Device Description

    reusable gowns

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a surgical gown and does not contain information about acceptance criteria and a study proving device performance as it relates to an AI or software-based medical device. Therefore, I cannot generate the requested table and answer the accompanying questions.

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