LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K210244
    Device Name
    Disposable Medical Face Mask
    Manufacturer
    Suzhou Bolisi Medical Technology Co., Ltd
    Date Cleared
    2021-07-12

    (164 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K210007
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Medical Face 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. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.

    Device Description

    Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (Spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (galvanized iron wire) to provide a firm fit over the nose.

    AI/ML Overview

    Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the Disposable Medical Face Mask:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria (for Level 2)Reported Device Performance
    Bacterial Filtration Efficiency (BFE) (ASTM F2101)≥98%Pass (≥98%)
    Differential Pressure (Delta-P) (EN 14683)
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1