Product Description
Earloop Face Mask (White), ASTM Level 3, Case of 500 (10 boxes of 50 masks)
Earloop face masks provide complete protection while remaining light and comfortable.
These are FDA approved, fluid resistant procedure masks, ASTM Level 3. These masks have been tested for bacterial filtration efficiency (BFE), particulate filrtation efficiency (PFE), and differential pressure (Delta P) by Nelson Labs. Test reports available upon request.
Standard: ASTM F2100: 2019
Layers: 3 Layers
BFE: >=98%
PFE: >=98%
Delta P: <5.0mm H2O/cm^2
Fluid Resistance: 160mmHg
Flame Spread: Class 1
Cleared by FDA (letter available upon request)
FDA Product Code: FXX, Mask, Surgical
Sterile?: Non-Sterile
NIH Link: https://accessgudid.nlm.nih.gov/devices/04897112130048
Available Colors: Blue, Light Pink, Green, White, Light Yellow, Lavender
Face Seal Fit: Loose fitting
Intended use and purpose: Fluid resistance protects wearer against large droplets, splashes or sprays of bodily or other hazardous fluids and protects patients from wearer's respiratory emissions.
Filtration: Degree of protection is indicated by bacterial filtration efficiency of >=98% and particulate filtration efficiency of >=98%.
Flame Spread: Class 1. As many places such as hospitals contain sources of oxygen, heat, and fuel, the ASTM F2100-11 standards include testing for flame resistance. Testing dictates that all procedure masks must withstand exposure to a burning flame (within a specified distance) for three seconds.
Delta P: <6.0mm H2O/cm^2. Delta P measures the air flow resistance of the procedure mask and is an objective measure of breathability.
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