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510(k) Data Aggregation

    K Number
    K220665
    Device Name
    Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
    Manufacturer
    Excellent Medical Technology Group Co., Ltd.
    Date Cleared
    2022-06-03

    (88 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

    Surgical Gown, Blue, Sterile and Surgical Gown, Blue, Non-Sterile intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EiO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.

    The Surgical Gowns meet the Level 3 ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing clearance letter for surgical gowns and does not contain information about software or AI/ML device studies. Therefore, I cannot provide the requested details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

    The document states that the surgical gowns meet "Level 3 ANSI/AAMI PB70:2012 Liquid Barrier and Performance Classification," which refers to a standard for protective apparel in healthcare. This is a performance standard for the physical product, not a study of an AI/ML algorithm.

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