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510(k) Data Aggregation

    K Number
    K984422
    Device Name
    STERILE BACK SURGICAL GOWN WITH HAND TOWEL
    Manufacturer
    MEDICAL STERILIZATION, INC.
    Date Cleared
    1999-04-02

    (113 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 Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both the surqical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

    Device Description

    Sterile Back Surgical Gown with Hand Towel

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a "Sterile Back Surgical Gown with Hand Towel." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.

    The letter is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It outlines general controls, potential additional controls, and contact information for further inquiries.

    Therefore, I cannot fulfill your request for information regarding performance criteria and study details based on the provided text. The document does not describe a study involving "acceptance criteria," "reported device performance" in the context of quantitative metrics, "sample sizes," "ground truth," "expert consensus," "MRMC studies," or "standalone performance."

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