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510(k) Data Aggregation

    K Number
    K222403
    Device Name
    Surgical Gown
    Manufacturer
    Guangzhou Fuzelong Hygiene Material Co., Ltd
    Date Cleared
    2023-01-26

    (170 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K214088
    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 the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 4 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). The Surgical Gowns are single use, disposable medical devices, provided sterile.

    Device Description

    The 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 polyester elastic closure by sewing, and the rest are made of SMS nonwoven material, in a blue color. It has been tested according to AAMI PB70:2012 and meet AAMI Level 4 barrier level protection for a surgical gown. The proposed devices are single use, disposable medical devices and EO that sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL

    AI/ML Overview

    This document describes the safety and performance of a Surgical Gown, not an AI-powered medical device. Therefore, many of the requested details about acceptance criteria for AI model performance and ground truth establishment are not applicable.

    However, I can extract the relevant acceptance criteria and the reported device performance for the physical surgical gown based on the provided text.

    Device: Surgical Gown (K222403)
    Intended Use: To protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures, meeting AAMI Level 4 barrier protection.

    1. Table of Acceptance Criteria and Reported Device Performance

    The device performance is assessed through non-clinical laboratory tests.

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance (Results)
    AATCC 42Assess resistance to water impact penetrationLevel 4, ≤1.0gPass
    AATCC 127Assess hydrostatic resistanceLevel 4, ≥50cmPass
    ASTM D5034Assess adequate tensile strengthWarp/Length ≥ 30N; Weft/Width ≥ 30NPass
    ASTM D5587Assess adequate tear resistanceWarp/Length ≥ 10N; Weft/Width ≥ 10NPass
    ASTM D1683Assess adequate seam strengthSleeve Seam: ≥ 30N; Armhole Seam: ≥ 30N; Shoulder Seam: ≥ 30NPass
    ASTM F1868Assess evaporative resistance of fabrics(Ref)≥0.06(kPa·m²/W)Pass
    ASTM F1671Resistance to Penetration by Blood-Borne Pathogens using Phi-X174 BacteriophageNo penetration (Assay Titer
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