FDA Registration Medical Devices

Foreign manufacturers can no longer export to the United States, non-NIOSH-approved respirators as well as decontamination

and bioburden reduction systems, using the Emergency Use Authorization (EUA), because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country.

ITB HOLDINGS LLC

390 North Orange Avenue, Suite 2300

Orlando, FL 32801

United States

T: +1 855-389-7344

T: +1 855-510-2240

T: +44 800-610-1577

www.fda.itbhdg.com

www.m.itbhdg.com

www.itbhdg.com