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510(k) Data Aggregation

    K Number
    K211353
    Device Name
    Medical Face Mask
    Manufacturer
    Shenzhen Lyttop Healthcare Limited
    Date Cleared
    2021-08-11

    (100 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203426
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Medical Face Mask (Model:LT0819, Ear loops) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

    Device Description

    The Proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all have Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene, iron and zinc. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

    AI/ML Overview

    The provided document describes the acceptance criteria and performance of the "Disposable Medical Face Mask (Model:LT0819, Ear loops)" manufactured by Shenzhen Lyttop Healthcare Limited. The device is classified as a Class II surgical apparel (21 CFR 878.4040) with product code FXX.

    1. Table of Acceptance Criteria and Reported Device Performance

    The device underwent non-clinical testing to demonstrate its performance against recognized standards, specifically for Level 2 medical masks according to ASTM F2100.

    Test MethodologyPurposeAcceptance Criteria (Level 2)Reported Device Performance
    Fluid Resistance Performance (ASTM F1862)To demonstrate the functionality of the subject device.29 out of 32 Pass at 120 mmHg3 lots, 32 out of 32 passes at 120 mmHg
    Particulate Filtration Efficiency (ASTM F2299)To demonstrate the functionality of the subject device.≥ 98%98.69%; 99.43%; 99.41% (for three lots)
    Bacterial Filtration Efficiency (ASTM F2101)To demonstrate the functionality of the subject device.≥ 98%99.89%; 99.9%; 99.9% (for three lots)
    Differential Pressure (Delta P) (EN 14683 Annex C)To demonstrate the functionality of the subject device.
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