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510(k) Data Aggregation

    K Number
    K202759
    Device Name
    Disposable medical surgical mask
    Manufacturer
    Chongqing COE Display Technology Co., Ltd.
    Date Cleared
    2021-04-21

    (212 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

    The disposable medical surgical 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 as sterile and non-sterile.

    Device Description

    The surgical mask consists of a mask body, a nose piece, and ear loops. The mask body is divided into three layers, the inner and outer layers are made of polypropylene fabrics; the middle layer is composed of Melt-blown cloth (polypropylene); the nose piece is made of polypropylene & iron (Fe), and the ear loops are made of nylon & spandex.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for a Disposable Medical Surgical Mask. This type of device is a physical product and not an AI/ML software device. Therefore, the questions regarding AI/ML specific criteria (such as training sets, ground truth establishment methods, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

    The document details the acceptance criteria and a study proving the device meets these criteria for a medical mask. The study focuses on bench testing and biocompatibility testing, which are standard for physical medical devices of this type.

    Here’s the breakdown based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Name of Test Methodology (standard)PurposeAcceptance CriteriaResults (for both sterile and non-sterile masks, as they show very similar results in the combined summary table)
    ASTM F 1862-17Fluid Resistance Performance29 out of 32 pass at 160 mmHgLot 1# pass at 160mmHg;
    Lot 2# pass at 160mmHg;
    Lot 3# pass at 160mmHg
    ASTM F2101-19Bacterial Filtration Efficiency≥ 98%Lot 1# 99.6%-99.9%;
    Lot 2# 99.7%-99.9%;
    Lot 3# 99.6%-99.9%
    EN 14683: 2019Differential Pressure (Delta-P)
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