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510(k) Data Aggregation

    K Number
    K202128
    Device Name
    Allmed Surgical Face Masks (Ear loops)
    Manufacturer
    Allmed Medical Products Co., LTD
    Date Cleared
    2021-06-03

    (307 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K160269
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Allmed Surgical Face Masks(Ear Loops) are intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The surgical face mask is a single use, disposable device provided non-sterile.

    Device Description

    Allmed surgical face masks (ear loops) are composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene meltblown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical face mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.

    AI/ML Overview

    The document describes the acceptance criteria and performance of the Allmed Surgical Face Masks (Ear Loops) as per their 510(k) summary. This is not a study of an AI-powered device, but rather a regulatory submission for a medical device (surgical face mask). Therefore, information related to AI-specific studies, such as multi-reader multi-case studies, standalone algorithm performance, number of experts for ground truth, or training set details, is not applicable or present in this document.

    Here's the information available:

    1. Table of acceptance criteria and the reported device performance:

    Test Method (Test Identification)Purpose (summarized)Acceptance Criterion (ASTM F2100 Level 3)Test Result
    ASTM F2101-Bacterial Filtration Efficiency (BFE)Compare bacterial control counts upstream and downstream to determine filtration efficiency.≥98%, AQL=4%Passed
    ASTM F2299-Particulate Filtration Efficiency (PFE)Evaluate non-viable particle filtration efficiency.≥98%, AQL=4%Passed
    EN14683:2019 Annex C-Differential PressureDetermine breathability by measuring differential air pressure.
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