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510(k) Data Aggregation

    K Number
    K211751
    Date Cleared
    2021-09-17

    (102 days)

    Product Code
    Regulation Number
    878.4040
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    WELLTRUST™ WT-III Mask with Flat Earloop are indicated as a protective nose and mouth covering for patients and healthcare personnel. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and bodily fluid and particulate material. These surgical masks are single use, disposable devices provided non-sterile.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a surgical mask. It primarily focuses on the regulatory approval and indications for use. It does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that would typically be associated with a study proving a device meets acceptance criteria.

    The letter states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the device wellTRUST WT-III Mask with Flat Earloop was deemed equivalent to existing surgical masks based on specific performance standards (which are not detailed in this document), rather than through a novel study testing new acceptance criteria.

    Therefore, I cannot fulfill your request for the detailed table and study information because the provided text does not contain that information.

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