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510(k) Data Aggregation

    K Number
    K212698
    Device Name
    Plus Medical Isolation Gown Level 3
    Manufacturer
    Foshan Nanhai Plus Medical Co Ltd
    Date Cleared
    2022-03-02

    (189 days)

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

    Plus Medical Isolation Gown Level 3

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

    Plus Medical Isolation Gowns Level 3 are intended to be worn by healthcare professionals to help protect both the patients and the healthcare workers from the transfer of microorganisms, body fluids, and particulate matters.

    The gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. The gown is a full-back design and is provided non-sterile, single use medical device.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but the provided text only contains an FDA 510(k) clearance letter for a medical isolation gown. It does not contain information about the acceptance criteria or a study proving that a device meets those criteria, specifically concerning an AI-powered device or diagnostic. The document pertains to a physical medical garment and its classification based on barrier protection standards, not an AI or software-based medical device.

    Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or human-in-the-loop performance for an AI device.

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