CE:EN 149 (4layer) Technoweb *Price range: Over 0 ~ Less 1,000,000 (EA) : US$0.45 Over 1,000,000 ~ Less 2,000,000 : $0.41 Over 2,000,000 ~ Less 3,000,000 : $0.39 Over 3,000,000 ~ : $0.37 *Payment: LC at sight (Open in Major bank) or Advanced payment FDA Device Classification: Class 2 per 21 CFR 878.4040 FDA Product Code: MSH FDA 510K Approval Number: K172500 Filter performance (as measured by Nelson Labs) : 98% Breathability : (Delta-P) 3.6 mm H2O/cm2 (at 8 L/min) Exhalation resistance: (TEB-APR-STP-003) 7.7 (mm H2O) Skin irritation & Cytotoxicity: None observed in laboratory animals. Cytotoxicity tested with NCTC Clone 929 (L-929) mouse fibroblasts. Skin irritation tested via patch test with continuous exposure to rabbits and guinea pigs. Splash resistance: ASTM F1862 Bacterial Filtration Efficiency (BFE): 99.9% Particle size filtration: 0.1 microns minimum Filtering media (material): TechnoWeb Performance stability: Filtration does not decline with time. TechnoWeb Mask does not rely on electrostatic forces. Intended use: Intended to be worn by operating room personnel to protect personnel and patient from the transfer of microorganisms, body fluids, and particulates. Production facility quality certifications: ISO 9001 & ISO 14001 Weight of respirator: 4.90 grams (including straps). Quantity per master carton: 400 respirators Dimensions & weight of master carton: 21 W x 11 D x 17 H inches, 4.8kg Expiration: TechnoWeb Mask material has no known expiry date References: Actively supplied to Federal Government (i.e. U.S. Department of Justice)
