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510(k) Data Aggregation

    K Number
    K192560
    Device Name
    Surgical Gown
    Manufacturer
    Shandong Kangli Medical Equipment Technology Co., Ltd.
    Date Cleared
    2020-05-22

    (248 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 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 surgical gowns meet the requirements for Level 3 classification.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a surgical gown and does not contain information about an AI/ML device. Therefore, it is not possible to describe acceptance criteria, performance studies, or related details typically found in submissions for AI/ML medical devices.

    The document clarifies that the surgical gown meets the requirements for a Level 3 classification according to ANSI/AAMI PB70:2012 for liquid barrier performance. However, this is a standard for physical barrier properties, not an acceptance criterion related to AI/ML performance.

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