Model PM-03 3ply Surgical Mask ASTM 3

Product Datasheet  - Click to view PDF

Testing Summary - Click to view PDF

Features

• ASTM Level 3 - enhanced fluid resistance
• Better Source Control - mask body tested for high particle filtration
• Single-use, disposable
• Assembled in California, USA

Materials

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

• Spunbond Polypropylene, White
• Electrostatically Charged Meltblown Polypropylene Filter Layer
• Spunbond Polypropylene, Blue
• Nylon/Spandex Round Elastic Earloops

Body Contacting Materials

• Spunbond Polypropylene
• Nylon/Spandex

Regulatory Class

Current: 

FDA Enforcement Policy May 20, 2020, Part E - Click link to read.

FDA fact sheet for health care personnel August 5, 2020 - Click link to read.

FDA EUA 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 significant risk of infection through inhalation exposure.
• Product is not intended to replace the need for FDA-cleared surgical masks or FDA-cleared or authorized respirators.

Pending: 

FDA EUA Appendix A List: Data submitted. Subscribe below for updates!

Third Party Testing

Production Samples Tested by Independent Certified Labs:

• BFE ≥98% (ASTM F2101 Bacterial Filtration Efficiency 3.0um)
• PFE ≥98% (ASTM F2299 Particle Filtration Efficiency 0.1um)
• Resistance to Penetration by Synthetic Blood @160mmHg (ASTM F1862)
• Flammability Class 1 (16 CFR Part 1610)
• Biocompatible (ISO 10993-1)

Important Note: Testing results are provided as is and do not represent official certification by ASTM. Results submitted to FDA for anticipated inclusion on EUA Appendix A List.

Minimum Order Quantity (MOQ): 5 packs of 50 each (250 masks)

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