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510(k) Data Aggregation

    K Number
    K222480
    Device Name
    Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)
    Manufacturer
    Foshan Nanhai Plus Medical Co., Ltd.
    Date Cleared
    2022-11-14

    (89 days)

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

    Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2)

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

    The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate material.

    The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) meets the level 2 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

    The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) have been validated using an ethylene oxide sterilization process. The Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2) are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) summary for a medical device, specifically a Standard Surgical Gown (AAMI Level 2) and Reinforced Surgical Gown (AAMI Level 2). It outlines the FDA's determination of substantial equivalence. However, it does not contain information related to software algorithm performance, clinical study acceptance criteria, or the details of a study proving a device meets such criteria.

    The document primarily focuses on:

    • Regulatory Clearance: The FDA's decision that the device is substantially equivalent to legally marketed predicate devices.
    • Indications for Use: The intended purpose of the surgical gowns (protection from microorganisms, body fluids, particulate matter) and their compliance with ANSI/AAMI PB70:2012 for liquid barrier performance (Level 2).
    • Sterilization Method: Validation of ethylene oxide (EtO) sterilization.
    • Device Models: A list of different models based on size, sterility, and whether they include hand towels and wrap.

    Therefore, I cannot provide the requested information about acceptance criteria and study details from the provided text, as this document is a regulatory approval letter, not a performance study report.

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