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510(k) Data Aggregation

    K Number
    K211440
    Device Name
    ASM-301 Level 3 Surgical Mask
    Manufacturer
    American Surgical Mask Company LLC
    Date Cleared
    2021-06-02

    (23 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

    ASM-301 Level 3 Surgical Mask

    AI/ML Overview

    This is a 510(k) clearance letter for a surgical mask (ASM-301 Level 3 Surgical Mask), which is a physical device, not an AI/ML powered medical device. Therefore, the questions related to acceptance criteria, study details, ground truth, and training sets for AI/ML devices are not applicable.

    The document describes the regulatory classification of the device and confirms its substantial equivalence to legally marketed predicate devices. It also outlines the indications for use of the surgical mask.

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