Ultraviolet-C Light-Based Bioburden Reduction Authorized for Certain N95 Respirators

The U.S. FDA issued an Emergency Use Authorization for the Lumin LM3000 Bioburden Reduction UV System on December 3, 2020. This innovative ultraviolet-C (UV-C) light-based bioburden reduction system is used in bioburden reduction of certain N95 respirators when there are insufficient supplies of filtering facepiece respirators resulting from the COVID-19 pandemic.

Manufactured by 3B Medical Inc., this is a Tier 3 system intended for bioburden reduction (or reduction of microorganisms) of 3M Model 1860 N95 respirators only, and only for single-user reuse, and is a supplement to the U.S. CDC reuse recommendations.