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510(k) Data Aggregation

    K Number
    K210860
    Device Name
    Comfort Guard Mask, level 1, Comfort Guard Mask, level 3
    Manufacturer
    GRI-Alleset, Inc
    Date Cleared
    2022-04-07

    (380 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

    Non-sterile, single use device designed to create a physical barrier between the mouth and nose of the wearer and potential contaminants in the imment. They are designed to be worn in the operating room, dental offices, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microogransims, bodily fluid and particulate matter.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA clearance letter for a medical device, specifically surgical masks. It does not contain information about the acceptance criteria for an AI/ML powered device, nor does it describe a study proving such a device meets acceptance criteria.

    Therefore, I cannot fulfill the request using only the provided input. The document is about the regulatory clearance process for a common medical device (masks), and not an AI/ML product.

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