Nano Mask - N95 Substantial Equivalent

Nano Mask - N95 Substantial Equivalent

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CONTACT US FOR CONTRACT PRICING/ BULK ORDERS

A Next-Generation FDA 510k approved N95 Substantial Equivalent

Contact us for Bulk Orders

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