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510(k) Data Aggregation

    K Number
    K222456
    Device Name
    High Protection Surgical Gown
    Manufacturer
    3A Medical Products Co., Ltd
    Date Cleared
    2023-03-12

    (209 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K221819,K212869
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    High protection surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the high protection surgical gown met the requirements for Level 4 classification.

    Device Description

    The proposed device is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed device is single use, disposable medical device and is provided in sterile. The proposed device is available in five product sizes, including S, M, L, XL, XXL. The barrier protection level for high protection surgical gowns meet AAMI Level 4.

    AI/ML Overview

    The medical device in question is a High Protection Surgical Gown (product code FYA, regulation number 21 CFR 878.4040, Class II).

    Here's an analysis of its acceptance criteria and the supporting study:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance
    Flammability (16 CFR Part 1610)Evaluate flammability of the test sample.Meets requirementsClass 1
    Hydrostatic Pressure (AATCC 127)Determine hydrostatic pressure of the test sample.≥50 cm H2O204.6 cm H2O
    Water Impact (AATCC 127)Determine hydrostatic pressure of the test sample (likely a typo, AATCC 42 is typically for impact penetration).≤1.0 g0.02g
    Breaking Strength (ASTM D 5034)Evaluate breaking strength of the test sample.≥30 NLongitude: 131.5N, Latitude: 75.2N
    Tearing Strength (ASTM D5587)Evaluate tearing strength of the test sample.≥10 NLongitude: 79.0N, Latitude: 33.8N
    Linting (ISO 9073-10)Evaluate linting of the test sample.Log10(particle count)
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