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510(k) Data Aggregation

    K Number
    K230383
    Device Name
    Savvy Surgical Mask - Level 3
    Manufacturer
    ALG Health LLC
    Date Cleared
    2023-03-06

    (21 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 Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry but this document does not contain information about the acceptance criteria or a study proving device performance as it is a 510(k) clearance letter for a surgical mask. It outlines regulatory information and confirms the device is substantially equivalent to legally marketed predicate devices. It does not include details on specific performance studies or acceptance criteria beyond indicating its classification as a "Level 3" surgical mask.

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