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    K Number
    K221977
    Device Name
    Disposable Surgical Gown (G4003)
    Manufacturer
    Xiantao Topmed Nonwoven Protective Products Co., Ltd.
    Date Cleared
    2022-10-20

    (107 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K211809
    Why did this record match?
    Device Name :

    Disposable Surgical Gown (G4003)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.

    In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile. The surgical gown has six sizes - S, M, L, XL, XXL and XXXL.

    Device Description

    The Disposable surgical gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.

    AI/ML Overview

    The document details the non-clinical testing performed for the Disposable Surgical Gown (G4003) to support its substantial equivalence claim.

    1. Table of acceptance criteria and the reported device performance

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    Tearing StrengthEvaluate the tearing strength of the test sample.≥ 10NPass: MD: average 52.03N, CD: average 29.15N
    Tensile StrengthEvaluate the breaking strength of the test sample.≥ 30NPass: MD: average 135.83N, CD: average 98.25N
    Seam StrengthEvaluate the seam strength of the test sample.≥ 30NPass: Average 45.18N
    Impact PenetrationEvaluate the water impact of the test sample.≤1.0 gPass: 0.16g max
    Hydrostatic PressureDetermine the hydrostatic pressure of the test sample.>50 cmPass: 52~98cm
    Thermal and Evaporative ResistanceEvaluate the evaporative resistance of the test sample.
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