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510(k) Data Aggregation

    K Number
    K202954
    Device Name
    Disposable Surgical Mask
    Manufacturer
    Xiamen Probtain Medical Techology Co., Ltd
    Date Cleared
    2021-07-02

    (275 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K100846
    Why did this record match?
    Reference Devices :

    K100846

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Surgical Mask 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(s), provided sterile.

    Device Description

    The Disposable Surgical Mask is 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 polypropylene, and the middle layer is made of melt blown polypropylene filter, the nose clip is made of plastic materials and iron wire, ear loop is made of spandex.

    The size of the disposable surgical mask is 17.5*9.5cm with tolerance +-5%, the length of the ear loop is 16cm with tolerance +-5%, and the length of the nose clip should no less than 8.0cm.

    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

    The document describes the non-clinical testing performed to demonstrate that the Disposable Surgical Mask (Model MP9017) manufactured by XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD meets its acceptance criteria and is substantially equivalent to a predicate device.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    ItemReported Device PerformanceAcceptance Criteria (Level 2)Result
    Fluid Resistance (ASTM F1862)32 out of 32 pass at 120 mmHg29 out of 32 pass at 120 mmHgPASS
    Particulate Filtration Efficiency (ASTM F2299)99.77%≥ 98%PASS
    Bacterial Filtration Efficiency (ASTM F2101)99.7%≥ 98%PASS
    Differential Pressure (Delta P) (EN 14683 Annex C)4.26 mmH2O/cm²
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