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510(k) Data Aggregation

    K Number
    K203775
    Device Name
    AIC disposable medical mask
    Date Cleared
    2021-03-12

    (74 days)

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

    The Aleen International Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AIC Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The 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 AIC Disposable Medical Masks are Blue and white color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The blue colorant is polypropylene (PP) master batch. The proposed device(s) are manufactured with 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 model of proposed device, tie-on, is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene. 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 facemask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device
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