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510(k) Data Aggregation

    K Number
    K172500
    Device Name
    Technoweb Surgical Mask
    Manufacturer
    Date Cleared
    2018-03-01

    (195 days)

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

    YTS GLOBAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Technoweb Sugical Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
    Device Description
    Technoweb Surgical Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. Technoweb Surgical Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of three nonwoven layers; inner and outer cover web with middle different filter web sandwiched in between.
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