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510(k) Data Aggregation

    K Number
    K133070
    Device Name
    SURGICAL FACE MASK (Ear Loops and Tie-on)
    Manufacturer
    B.H. MEDICAL PRODUCTS CO., LTD.
    Date Cleared
    2015-06-22

    (630 days)

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

    B.H. MEDICAL PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The surgical face masks are 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
    The surqical face masks are pleated 3 plys sinqle use, disposable masks. Inner layers and outer layers are made of spun-bond polypropylene. Middle layer is made of melt blown polypropylene filter. Earloops are Knitted Elastic loops (not made with natural rubber latex). Tieon is made of spun-bond polypropylene. The nose piece is a malleable aluminum wire.
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