Conform to NIOSH 42 CFR Part 84 Standard as N95 Class. NIOSH N95 approved for 95% filtration efficiency against particles (0.3µ) and aerosols free of oils. NIOSH N95 certified single-use disposable respirators. Manufacturing certified ISO 9001 for quality management systems. Manufacturing certified ISO 13485 for quality management systems for medical devices. Manufacturing certified ISO 14001 to continuously mitigate our environmental impact.