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510(k) Data Aggregation

    K Number
    K220435
    Device Name
    SEJONG Surgical Gown Soft
    Manufacturer
    Sejong Healthcare Co., Ltd.
    Date Cleared
    2023-02-10

    (361 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K190950
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SEJONG Surgical Gown Soft is sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter. The SEJONG Surgical Gown Soft meets the Level 3 requirements of ANSI/AAMI PB70:2012. Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. The SEIONG Surgical Gown Soft has been validated using ethylene oxide (EtO) sterilization process. The SEJONG Surgical Gown Soft is also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EO sterilization method according to ISO 11135 prior to being provided to the end user.

    Device Description

    The SEJONG Level 3 Surgical Gowns is a non-reinforced design and available in 4 sizes ranging from medium to XX-large. Below Table provides model number of the Sejong Surgical Gown Soft. The chest and sleeve critical zones, as well as the overall body, are constructed from a blue polyolefin/polypropylene SMMMS (Spunbound, meltblown, meltblown, spunbound). Sejong Surgical Gown Soft has been tested according to ANSI/AAMI PB70:2012 and meets and AAMI Level 3 barrier level protection for a surgical gown. Sejong Surgical Gown Soft is nonreinforced, single use, disposable medical device that will be provided in both a sterile packaging configuration and a variety of sizes.

    AI/ML Overview

    This document describes the premarket notification (510(k)) for the SEJONG Surgical Gown Soft, manufactured by Sejong Healthcare Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the Medline Level 3 Surgical Gown (Sirus Non-Reinforced) (K190950).

    As this is a 510(k) submission for a surgical gown, the "device" in question is not an AI/software medical device, but rather a physical apparel. Therefore, many of the typical acceptance criteria and study components associated with AI/software performance (such as sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, and human-in-the-loop performance) are not applicable here. The "performance" of this device is assessed through non-clinical laboratory testing to ensure it meets established safety and performance standards for surgical apparel.

    Here's the breakdown of the information as it relates to the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria and performance data are presented in a table under Section VII. "Non-Clinical Test Conclusion."

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    AATCC 42Assess resistance to water impact penetrationLevel 3, ≤1.0gPass
    AATCC 127Assess hydrostatic resistanceLevel 3, ≥50cmPass
    ASTM D5034Assess adequate tensile strengthLength ≥ 30N
    Width ≥ 30NPass
    ASTM D5587
    ASTM D5733Assess adequate tear resistanceLength ≥ 10N
    Width ≥ 10NPass
    ASTM D1683Assess adequate seam strengthSleeve Seam: ≥ 30N
    Armhole Seam: ≥ 30N
    Shoulder Seam: ≥ 30NPass
    Bursting Strength
    ASTM D3787
    ISO 13938-1Assess adequate bursting resistance≥ 5.80 psiPass
    ISO 9073-10Assess acceptable lint and other particles generation in the dry stateLog10
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