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510(k) Data Aggregation

    K Number
    K221753
    Device Name
    Kangbeier Child Surgical Mask
    Manufacturer
    Xinxiang Kangbeier Medical Technology Co., Ltd.
    Date Cleared
    2023-12-21

    (553 days)

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

    Xinxiang Kangbeier Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kangbeier Child Surgical Mask is intended to be worn by the patient (ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The Kangbeier Child Surgical Mask is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
    Device Description
    The Kangbeier Child Surgical Mask is composed of three layers of materials and pleated to form the mask. The inner layer is composed of spun-bond nonwoven polypropylene, the middle layer is meltblown polypropylene filter material, and the outer layer is spunbond nonwoven polypropylenen. The color on the outer layer is consists of Phthalocyanine Blue and PE wax and PP. Masks are held in place on wearer with elastic spun-bond polypropylene earloop and contain a malleable aluminum nosepiece strip. The Kangbeier Child Surgical Mask is appropriately sized to the smaller faces of children across a diverse population. The Kangbeier Child Surgical Mask is a single use, disposable device, provided nonsterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices.
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    K Number
    K213920
    Device Name
    Kangbeier Surgical Mask (Model: KBR-1001)
    Manufacturer
    Xinxiang Kangbeier Medical Technology Co., Ltd.
    Date Cleared
    2022-01-16

    (32 days)

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

    Xinxiang Kangbeier Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable surgical face masks are intended to be worn to protect 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 is a single use, disposable device provided non-sterile.
    Device Description
    The Kangbeier Surgical Mask (Model: KBR-1001) is non-sterile, disposable, single-use surgical mask. It is manufactured with three layers, the inner and outer layers are made of non-woven, spun-bond polypropylene, while the middle filter layer is made of a non-woven, melt-blown polypropylene.
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