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510(k) Data Aggregation

    K Number
    K223686
    Device Name
    Medical Protective Masks
    Date Cleared
    2023-02-07

    (60 days)

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

    Qinhuangdao Taizhi Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Medical Protective Masks is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids and particulate material. It is intended for use 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 mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in black color.
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    K Number
    K212205
    Device Name
    Medical Protective Masks
    Date Cleared
    2021-10-14

    (91 days)

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

    Qinhuangdao Taizhi Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Medical Protective Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use 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 mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The mask is a single use, disposable device, provided non-sterile in white color.
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    K Number
    K211451
    Device Name
    Disposable Surgical Mask (non sterile)
    Date Cleared
    2021-08-25

    (107 days)

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

    Qinhuangdao Taizhi Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Disposable surgical mask (non sterile) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use 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 Disposable surgical mask (non sterile) is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PE (polyethylene) with dual-Galvanized wire. The Disposable surgical mask (non sterile) will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
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