The American Society of Testing and Materials (ASTM) is the organization responsible for establishing criteria and testing methods to delineate performance specifications for face masks used in healthcare. ASTM published an updated description of performance requirements in 2011, and these are recognized as the industry standard for healthcare face masks.  Face masks fall under ASTM Standard F2100-11.

In developing ASTM F2100-11, the organization tested material used to make medical face masks on five performance metrics. Based on their test scores, ASTM assigns a numerical rating for the barrier performance of the material:

• Level 1 - for low risk of fluid exposure
• Level 2 - for moderate risk of fluid exposure
• Level 3 - for high risk of fluid exposure

The five performance metrics and their related tests are:

• Fluid Resistance – Test ASTM F1862
  This test evaluates the resistance of a medical face mask to penetration by a small volume (~2 mL) of synthetic blood at a high velocity (80 mmHg, 120 mmHg, or 160 mmHg). The mask either passes or fails based on visual evidence of synthetic blood penetration.
• Breathability – Test MIL-M-36954 C: ΔP
  This test determines the face mask’s resistance to airflow. A controlled flow of air is driven through the mask, and the pressure before and after is measured. The difference in pressure is divided by the surface (in cm2) of the sample. A lower breathing resistance indicates a better comfort level for the user.
• Bacterial Filtration (BFE) – Test ASTM F2101
  This test measures the percentage of bacteria larger than 3 microns filtered out by the mask. The challenge material used is Staphylococcus aureus.
• Particulate Filtration (PFE) – Test ASTM F2299
  This test measures the percentage of particles larger than 1 micron filtered out by the mask. The challenge material used consists of latex aerosol concentrations in a controlled airflow chamber.
• Flammability – Test 16 CFR Part 1610: Flame Spread
  This test exposes the face mask material to a flame and measures the time required for the flame to proceed up the material a distance of 127 mm (5 inches). Class 1 means the material exhibits normal flammability and is acceptable for use in clothing.

An ASTM Level 3 mask protects your nose and mouth against splashes and sprays of blood and other bodily fluids, as well as bacteria and particulate matter of the sizes indicated in the above table; however, face masks do not provide respiratory protection against airborne diseases. For that purpose, a respirator is required.

• FDA Approved
• Box of 50 
•  Soft earloops with adjustable nose piece.
• Non-tearing pleat design
• Especially useful for laser procedures that generate harmful airborne particles
• Multi-layer non-woven polypropylene
• One size fits all

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