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510(k) Data Aggregation

    K Number
    K213806
    Device Name
    Disposable Medical Face Mask
    Manufacturer
    Xiantao Zhibo Nonwoven Products Co., Ltd
    Date Cleared
    2022-03-12

    (96 days)

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

    Xiantao Zhibo Nonwoven Products Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Medical 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 is a single use, disposable device(s), provided non-sterile.
    Device Description
    Disposable Medical Face Mask is composed of Nylon & Spandex Ear loops, High Density Polyethylene nose clip, Inner layer Non-woven fabric, Middle Melt-blown Non-woven fabric and outer Non-woven fabric. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. Disposable Medical Face Mask feature pleats. Three pleats are used to expand the mask such that it covers the area from the nose to the chin. The type is ear loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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