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510(k) Data Aggregation

    K Number
    K203801
    Device Name
    Disposable Surgical Face Mask
    Date Cleared
    2021-04-06

    (99 days)

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

    Anhui Jiabao Protective Equipments 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 material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
    Device Description
    The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On (model: JB-DM04) or Ear Loops (model: JB-DM03) way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. 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 JB-DM04 of proposed device, tie-on, is held in place over the user's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene. The model JB-DM03 of proposed device, ear loops, is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and spandex. The nose chip 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 PE and iron. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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