Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K210698
    Device Name
    ECOMA Level 2 Disposable Surgical Mask with Ear Loops
    Date Cleared
    2021-08-19

    (164 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xianning Eco Medical Articles Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The surgical 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. This is a single use, disposable device(s), provided non-sterile.
    Device Description
    The ECOMA surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), filter layer (polypropylene melt blown, white), and inner layer (polypropylene spunbond, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical face mask is a single use, disposable device, provided non-sterile.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1