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510(k) Data Aggregation

    K Number
    K203101
    Device Name
    Secure Wear USA Surgical Face Mask
    Manufacturer
    Secured Ortho Manufacturing of America, LLC
    Date Cleared
    2021-03-31

    (168 days)

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

    The Secure Wear USA™ Surgical Face Mask is intended to be worn to protect both the patient and the healtheare professional from transfer of microorganisms, body fluids, and particulate material. The surgical 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, nonsterile, disposable device.

    Device Description

    Secure Wear USA™ Surgical Face Mask Product models: Surgical Face Mask, Ear Loop, Level 1: Surgical Face Mask, Ear Loop, Level 2: Surgical Face Mask, Ear Loop, Level 3; Surgical Face Mask, Tie-on, Level 1; Surgical Face Mask, Tie-on, Level 2; Surgical Face Mask, Tie-on, Level 3.

    AI/ML Overview

    This document is a 510(k) clearance letter for a surgical face mask and does not describe acceptance criteria, a study, or device performance against such criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide information about performance studies for the device itself.

    Therefore, I cannot extract the requested information from the provided text.

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