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