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510(k) Data Aggregation

    K Number
    K982058
    Device Name
    ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
    Manufacturer
    ENCOMPASS GROUP, LLC.
    Date Cleared
    1999-01-14

    (217 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

    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.

    Device Description

    A reusable surgical gown fabricated from 99% polyester, 1% carbon, chemically treated fabric and designed to provide fluid protection through up to 150 laundry/sterilization cycles.

    AI/ML Overview

    This document is a 510(k) summary for a reusable surgical gown and does not contain information about an AI/ML powered medical device. Therefore, I cannot provide a response for the acceptance criteria and study as requested.

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