Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K210391
    Device Name
    Single-use medical face mask
    Date Cleared
    2021-07-22

    (162 days)

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

    Zhuhai Herald Datanetics Limited.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Single-use medical face mask is intended to be worn to protect 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, provided nonsterile.
    Device Description
    The Single-use medical face mask is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven 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 not made with natural rubber latex. The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1