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510(k) Data Aggregation

    K Number
    K203565
    Device Name
    Surgical 3D Mask
    Manufacturer
    Inno Lifecare
    Date Cleared
    2021-10-19

    (316 days)

    Product Code
    FXX
    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

    The Surgical 3D Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. The surgical mask is a single use, provided nonsterile.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter for a device named "Surgical 3D Mask". This document establishes that the device is substantially equivalent to a predicate device and states its indications for use. However, it does not contain any information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, or how ground truth was established.

    Therefore, I cannot fulfill your request for that specific information based on the text provided. The document focuses solely on the regulatory clearance for the device, not its performance evaluation details.

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