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510(k) Data Aggregation

    K Number
    K962666
    Device Name
    BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN
    Manufacturer
    BEMISS-JASON CORP., TRIAD MEDICAL DIV.
    Date Cleared
    1997-02-27

    (233 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

    Disposable / Single Use Only Surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) summary for surgical gowns and does not contain information about a device that undergoes a study with acceptance criteria, sample sizes, expert involvement, or any of the other specific details requested in the prompt. The document is about demonstrating substantial equivalence of new surgical gowns to existing ones based on material similarities, intended uses, and safety/effectiveness, rather than reporting on the performance of an AI/software device.

    Therefore, I cannot extract the requested information from the provided text.

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