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510(k) Data Aggregation

    K Number
    K220302
    Device Name
    Disposable surgical face mask
    Date Cleared
    2022-11-16

    (287 days)

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

    Shandong Aida Medical Products Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 materials 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 proposed device is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The proposed device is manufactured with three layers, the inner and outer layers are made of spun-bond Nonwoven fabric polypropylene, and the middle layer is made of melt blown polypropylene filter. The filter fiber is used for particle adsorption, mechanical sieve retention, inertial deposition, and electrostatic adsorption deposition, so that the air containing harmful substances is filtered through the filter material of the mask and then inhaled or exhaled. The style of the device, ear loops, is held in place over the users' mouth and nose by two ear loops welded to the facemask. The ear loops are not made with natural rubber latex but made of polyester and spandex. The nose piece contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and iron. The proposed device should be stored in a dry, ventilated and pollution-free area; the temperature should be 0-40 ℃, and the humidity should not be higher than 80%; Keep away from fire sources, avoid dust exposure and direct sunlight. The proposed device is sold non-sterile and is intended to be a single use, disposable device.
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