Lutema
ASTM Level 3, 4-layer Face Masks for Adults (50 Pack) for Adults MADE IN USA, FDA EUA
ASTM Level 3 Protection. FDA Authorized. Made in the USA.
Serious protection for business and personal use. Our 4-layer procedural face masks meet ASTM Level 3 barrier protection standards and are listed under FDA Emergency Use Authorization — designed and manufactured in San Diego, California by Lutema / Breathh, Inc.
Buy 2+ and Save — discount automatically applied at checkout!
Why You'll Love It
- ASTM Level 3 certified — highest barrier protection standard for procedural masks
- 4-layer protection with 99.9%+ particulate and bacterial filtration efficiency
- FDA Emergency Use Authorized — suitable for healthcare personnel and general public
- Soft elastic earloops designed for all-day comfort
- Breathable fabric that blocks dust, air pollution, and droplets
- Made in the USA — Designed & manufactured in San Diego, CA
- FDA Registered Manufacturer — Registration No. 3017171515
- 50 masks per package — please dispose of properly
Third-Party Lab Tested
ASTM (American Society for Testing and Materials) certification demonstrates compliance to Level 3 barrier protection standards.
| Test Type | Laboratory | Results |
| Flammability | Eurofins | PASS CLASS 1 |
| Synthetic Blood Penetration | Eurofins | PASS 160mmHg LEVEL 3 |
| Differential Pressure | Eurofins | 49.4 ± 2.7 Pa/cm² |
| Differential Pressure | Nelson Labs | 48.4 ± 3 Pa/cm² |
| Particulate Filtration Efficiency (PFE) | Nelson Labs | 99.924% |
| Sodium Chloride Aerosol Challenge | Nelson Labs | 97.89% |
| Bacterial Filtration Efficiency (BFE) | Eurofins | 99.82% |
| Particulate Filtration Efficiency (PFE) | Eurofins | 99.93% |
From the Donveli Team
Donveli Co-Founder Eddie Phanichkul helped develop and bring these masks to market. Donveli / M2Z LLC is the only authorized distributor of Lutema Made in the USA masks. Have a special need? Eddie is also donating or deeply discounting for non-profits.