USA-Made KN95 Face Mask Cleared

February 8, 2022

Lindon, Utah-based PuraVita Medical has received the FDA’s 510(k) clearance for its domestically made medical-grade KN95 face masks.

“Our KN95 masks are the only KN95s in the world that are FDA 510(k) approved, ASTM Level 3 and Made in USA,” the company said.  ASTM Level 3 is the FDA's highest rating for medical and surgical face masks.

PuraVita was founded in 2020 specifically to produce high-quality face masks. The newly cleared KN95 masks cost just under $20 each.

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