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510(k) Data Aggregation

    K Number
    K203455
    Device Name
    Disposable Medical Mask
    Manufacturer
    Fujian Kang Chen Daily Necessities CO., LTD
    Date Cleared
    2021-09-13

    (294 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K201691
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Medical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The Disposable Medical mask is 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.

    Model: k0450, blue color, and Level 2 barrier level per ASTM F2100.

    Device Description

    Disposable Medical Mask are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.

    AI/ML Overview

    This document is a 510(k) summary for a Disposable Medical Mask (Model: k0450). It focuses on demonstrating substantial equivalence to a predicate device. The information provided is for a medical device (surgical mask), not a software or AI device. Therefore, the concepts of human readers, AI assistance, effect size, training sets, and ground truth establishment in the context of AI/ML models are not applicable to this document.

    The acceptance criteria and performance data pertain to the physical characteristics and barrier performance of the surgical mask.

    1. Table of acceptance criteria and the reported device performance

    Test PurposeTest MethodAcceptance CriteriaReported Device Performance
    Fluid Resistance Performance (mmHg)ASTM F1862≥ 29 Out of 32 pass at 120 mmHg32 out of 32 pass at 120 mmHg
    Particulate Filtration Efficiency Performance (%)ASTM F2299≥ 98%99.9%
    Bacterial Filtration Efficiency Performance (%)ASTM F2101≥ 98%99.9%
    Flammability class16 CFR 1610Class 1Class 1
    Differential Pressure (Delta-P) (mm H2O/cm2)ASTM F2100-19
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