Nano Mask-N95 Innovation Sustantial Equivalent

  • A NEXT-GENERATION FDA 510K APPROVED N95 SUBSTANTIAL EQUIVALENT

     

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    US FDA REGULATORY DETAILS

    Regulation Name: Surgical Apparel

    Regulatory Class: Class II

    Product Code: FSH

     

    510(k) Registration No: K172500

     

    Trade/Device Name: Technoweb Surgical Mask

    Common Name: Surgical Respirator

     

    Predicate Device: 3M VFlex 1805/1805S (N95)

     

    IFU: 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 microorganism, body fluids and particulate material

     

    Other:  CE FFP2 NR – Approved for Sale EU CE-Mark, European SGS, REACH, RoHS

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