Model EL-05 earloop 5-Layer Surgical Mask

Product Datasheet EL-05  - Click to view PDF

Summary of 3rd-Party Testing Results EL-05 - Click to view PDF

Features

• Two Layers of Made in USA electrostatic filtration material
• Level 2 Liquid Barrier - ASTM F1862
• Comfort shape - minimal to no contact with mouth and lips. 
• Better fit - mask shape conforms better against face then typical pleated masks, leaving less air gaps
• Earloops
• Made in USA (with domestic and imported material)

Materials

Masks are made of nonwoven, hypoallergenic fabrics and are joined together by ultrasonic welding:

• Spunbond Polypropylene, White
• 2 layers of Electrostatically Charged Meltblown Polypropylene Filter
• "Hot Air Cotton" - layer of lofted Polypropylene for structure
• Spunbond Polypropylene, White
• Nylon/Spandex Elastic Earloops

Body Contacting Material:

• Spunbond Polypropylene
• Nylon/Spandex Elastic

Third Party Testing Data
Production Samples Tested by Independent Labs:

• Sodium Chloride Aerosol Challenge 0.3um ≥95% (Nelson Labs)
• Inhalation/Exhalation Resistance (Nelson Labs)
• Resistance to Penetration by Synthetic Blood, Level 2 (Eurofins)
• Flammability Class Rating, Clothing Safe (Eurofins)

Important Note: Testing results do not represent official certification by NIOSH. Testing data is shown for informative purposes only. No claim of certification or approval by NIOSH is made by Phenotype Pharmaceuticals. Data is provided as is and is applicable to the mask body only. Proper end-user fit determines ultimate effectiveness. It is the responsibility of the end-user to perform fit test and determine if this equipment is suitable for use. Phenotype Pharmaceuticals is not responsible or liable if equipment is used for purposes beyond intended use as stated in model datasheet.

Regulatory Class

Current: 

FDA Enforcement Policy for Surgical Masks: May 20, 2020, Part E - Click link to read.

FDA EUA Legal Disclaimers:

• These surgical masks are intended to be used in healthcare settings by healthcare personnel (HCP) as personal protective equipment (PPE) to provide a physical barrier to fluids to prevent HCP exposure to respiratory droplets during surgical mask shortages resulting from the COVID-19 pandemic.
• Surgical masks are not intended to provide protection against pathogenic biological airborne particulates and are not recommended for use in aerosol generating procedures and any clinical conditions where there is a significant risk of infection through inhalation exposure.
• This product is not intended to replace the need for FDA-cleared surgical masks or FDA-cleared or authorized respirators.

Minimum Order Quantity: 5 Packs of 20 each (100 masks)

Inquire for price.