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510(k) Data Aggregation

    K Number
    K202126
    Device Name
    Disposable Surgical Mask
    Date Cleared
    2021-06-08

    (312 days)

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

    Shenzhen Peninsula Medical Co. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
    Device Description
    The Disposable Surgical Mask is Flat Pleated style mask, utilizing ear loops way for wearing, and they all has nose piece design for fitting the Disposable Surgical Mask around the nose. The Disposable Surgical Mask are manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8) and the middle layer is made of melt blown polypropylene filter. 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 Disposable Surgical Mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Disposable Surgical Mask is in the middle layer of Disposable Surgical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of malleable aluminum wire. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Surgical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm. The Disposable Surgical bag packaging material is Polypropylene and box packaging are carton.
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