Posted on May 17 2020
Makrite Model N95-9500 have a 510(K) number for the medical market. They have been evaluated, tested, and approved by NIOSH as per the requirements in 42 CFR Part 84.
N95s effectively filter out a minimum of 95 percent of airborne aerosols particles that meets the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 classification of air filtration.
NIOSH and FDA approvals: See Certifications and Reports.