Healthcare Personnel Masks, FDA Listed Product Prioritized for First Responders
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Made in the USA, Lutema Brand masks are a comfortable fit! With soft elastic ear loops and breathable fabric, Lutema Brand masks help to block dust & air pollution. Made for business and personal care applications, this mask intended for use by the general public and healthcare personnel. Our masks are made using fully automated technology designed by MI Technologies robotics engineers across the globe, using top quality materials in a clean and controlled facility that is ISO 9001:2015 Certified.
- Lutema disposable masks are Made in the USA
- Material: Our 4 Layer Face Mask feature 2 front layers of 30GSM polypropylene fabric and a AAA+ layer of 99% melt-blown filter, followed by an inside liner of soft hypo-allergenic polypropylene fabric.
- Ergonomic Design - Light weight, comfortable, durable & stretchable straps with dual point attachments, ensuring reliable protection. High-quality elastic ear bands are comfortable to wear.
- Premium Quality - Advanced skin-friendly non-woven and melt-blown fabric provides easy breathing for long hours and high efficiency in filtering out particles.
- Designed & Manufactured in San Diego, California facility. Our automated system allow minimal human contact in both manufacturing and packaging, allowing both product quality and efficacy.
Manufacturer's FDA Registration No. 3017171515
✅ The Testing
ASTM (American Society for Testing and Materials) certification demonstrates compliance to Level 3 barrier protection standards!
(click to view/download)
|Synthetic Blood Penetration||EUROFINS|
|Differential Pressure||EUROFINS||✅ 49.4 ± 2.7 Pa/cm²|
|Differential Pressure||NELSON||✅ 48.4 ± 3 Pa/cm²|
|Particulate Filtration Efficiency (PFE%)||NELSON||✅ 99.924%|
|Sodium Chloride Aerosol Challenge||NELSON||✅ 97.89%|
|Bacterial Filtration Efficiency (BFE%)||EUROFINS|
|Particulate Filtration Efficiency (PFE%)||EUROFINS||
✅ 99.86% LOT 1
✅ 99.88% LOT 2
✅ 99.85% LOT 3
Updated December 21, 2020
PLEASE NOTE: This is NOT a medical-grade mask and is not intended as a replacement for medical-grade equipment or other recommended measures to stop the community spread of any viruses, including social distancing, washing your hands and refraining from touching your face.
Impressive service and excellent quality of masks.