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510(k) Data Aggregation

    K Number
    K211275
    Device Name
    AirMax Procedure Mask
    Manufacturer
    PremiumEStore, LLC
    Date Cleared
    2021-05-25

    (28 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

    This mask is intended to be worn to protect both the patient and healthcare personnel fromtransfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "AirMax Procedure Mask." This document primarily focuses on the regulatory clearance process, stating that the device is substantially equivalent to a predicate device, and outlines the general controls and regulations applicable to such a device.

    Crucially, the document does not contain information about acceptance criteria, specific device performance metrics (other than general indications for use), details of a study that proves the device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

    Therefore, I cannot fulfill your request for this information based on the provided text. The document is administrative and regulatory in nature, not a technical report detailing performance study results.

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