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510(k) Data Aggregation

    K Number
    K210429
    Device Name
    Disposable Surgical Face Mask
    Manufacturer
    Jiangxi Heying Pharmaceutical Co., Ltd
    Date Cleared
    2021-06-02

    (110 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K100846
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Face Mask is 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 a single use, disposable device(s), provided sterile and non-sterile.

    Device Description

    The Disposable Surgical Face Masks are composed of mask body, nose clip and ear loop. The mask is composed of three layers: the inner and outer layers are made of spun-bond nonwoven fabric, and the middle layer is made of melt blown non-woven fabric. The nose clip is made of polyethylene and iron material, ear loop is made of nylon and spandex material. The size of the disposable surgical mask is 17.5*9.5cm with tolerance±5%cm, the length of the ear loop is ≥ 10.0cm. The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.

    AI/ML Overview

    This is a 510(k) premarket notification for a Disposable Surgical Face Mask, which is a Class II medical device. The document summarizes the performance testing and substantial equivalence to a predicate device.

    Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test MethodologyPurposeAcceptance CriteriaReported Device PerformanceResult
    Functional TestsASTM F2100 Level 3 Requirements
    Fluid Resistance (ASTM F1862)To demonstrate the functionality of the subject device.29 out of 32 pass at 160 mmHg for Level 332 out of 32 per lot pass at 160 mmHg (3 non-consecutive lots tested for sterile and non-sterile)PASS
    Particulate Filtration Efficiency (ASTM F2299)To demonstrate the functionality of the subject device.≥ 98%Lot1: 99.41% (before sterile), 99.50% (sterile), 99.44% (after aging)
    Lot2: 99.36% (before sterile), 99.26% (sterile), 99.18% (after aging)
    Lot3: 99.36% (before sterile), 99.29% (sterile), 99.27% (after aging)PASS
    Bacterial Filtration Efficiency (ASTM F2101)To demonstrate the functionality of the subject device.≥ 98%Lot1: 99.77% (before sterile), 99.79% (sterile), 99.74% (after aging)
    Lot2: 99.80% (before sterile), 99.83% (sterile), 99.77% (after aging)
    Lot3: 99.80% (before sterile), 99.78% (sterile), 99.76% (after aging)PASS
    Differential Pressure (EN 14683)To demonstrate the functionality of the subject device.
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