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