Level 3 Surgical Mask – Box of 50

Key Features

– Single-use Disposable
– Level 3 Surgical Face Mask
– Breathable Fabric
– Comfortable Form Fit
– Particle Filtration Efficiency
– 4 Protective Non-Woven Melt Blown Layers
– FOB CA Pricing

FDA Registration
– Classification Product Code FXX
– Device Classification Class II Medical Device
– 510(k) Authorization K050689
– FDA Registration Number 9613778
– Date Approved October 26, 2005

Nelson Labs Test Results (ASTM 3)
– Flammability Rating IBE, 5/5
– Synthetic Blood Penetration Resistance None Seen 31/32
– Bacterial Filtration efficiency Average 99.9%
– Latex Particle Challenge (PFE) 98.5 to 99.52%
– Delta P (mm H20/cm²) 3.2 to 3.9
– Delta P (Pa/cm²) 31.5 to 37.8

Certification: FDA 510K, CE, ASTM F2100 Level 3, ISO 13485

Download Test Reports
– Particle Filtration Efficiency
– Flammability Test
– Bacterial Filtration Efficiency (BFE) & Differentia Pressure (Delta P)
– Synthetic Blood Penetration
– ISO13485 Certification

Level 3 Surgical Mask Datasheet

HCA Product Number: OP-FM-Surgical