Technology
Why Perfect Mask?
Comfort
Fit
Medical Grade
Filters
Effective
Filtration
Enhanced Liquid
Barrier
Material Construction
When choosing the materials to create our mask we had to solve two problems. First, the material had to be strong in filtration against airborne particles. Second, the material had to be breathable and safe for users to use. The solution was to use Polypropylene. Polypropylene (PP) is a thermoplastic “addition polymer” made from the combination of propylene monomers. It has the following properties:
- It is chemically resistant: making it safe for users as diluted bases and acids do not react readily with polypropylene.
- It has high Elasticity and Toughness: to provide flexibility for different user faces.
- It has Fatigue Resistance: allowing it to conform and stay to the user's face after a lot of torsion, bending, and/or flexing.
- Insulation: polypropylene has a remarkably high resistance to electricity to protect users against shock.
Using our state-of-the-art melt-blown and non-woven technology, we were able to convert our high-quality polypropylene and provide it with even more unique properties. By using our proprietary spun bond technique, the polypropylene gains the property to have higher tensile strength and provides a smaller pressure drop. This makes it perfect for the mask’s outer and inner layers as it can conform to the user’s face as well as provide great breathability.
Our unique melt-blown technique provided the Polypropylene with submicron filaments. These filaments produce extraordinary filtration properties. On top of this filtration we provided an electrostatic layer of charge on the outer layer for increased protection by repelling particles.
The nose beam was developed to be strong and maintain the shape of the user's face. To achieve this, a high grade of iron was used as it provided the strength and flexibility required. Nested deep between the layers, the nose beam is strong and flexible, and can conform to most face shapes and sizes.
The ear loops were designed with premium quality material to provide the perfect level between comfort and fit. Capitalizing on the stretching properties of Spandex, the ear loops are non-hypoallergenic, and fit comfortably for a wide range of users.
Performance Metrics
| BFE (Bacterial Filtration Efficiency) | PFE (Particle Filtration Efficiency) | Liquid Protection | Differential Pressure |
|
≥ 95% at 3.0 micron |
≥ 95% at 0.1 micron |
80 mm Hg |
<5 mm H20/cm2 |
Understanding These Metrics
Before diving into the details of the Mask performance data, it is important to understand where these benchmarks came from and from who. The American Standard Testing of Materials (ASTM) is an organization that develops testing standards to provide safety and quality to overall public life. For medical masks, the performance is derived from ASTM F2100, but what does these performances mean?
For starters, “PFE” stands for particulate filtration efficiency, and this test measures how much particles the mask filtrates based on a specified diameter. At what diameter you ask? Well, that choice is up to the Mask developer, but for our mask we selected the most stringent diameter (i.e. 0.1 microns. That means our mask is capable of filtrating against particles that are 0.1 microns or greater. The picture to the right gives perspective on how small that is and what exactly it can filtrate.
Liquid Pressure is another metric to measure how much projectile liquid it can protect against. Based on our non-woven polypropylene, it can provide 80 mm HG of protection.
Differential Pressure represents how ‘breathable’ the mask can be. It measures the difference between the air pressure inside the mask with the air pressure outside of the mask. The smaller the differential pressure the more breathable the mask is. Our Mask has a differential pressure of less than 5 mmH2O making the difference between wearing the mask and not wearing feel “minimal”.
While this may sound simple, there is a balancing act between breathability and protection. The smaller the filtration gap, the more it can protect you, however this also makes the mask less breathable. With our patented melt-blown/non-woven technology and innovative engineering process we have discovered a new way of providing that high level of protection you need without sacrificing breathability.
Bacteria Filtration Efficiency (BFE) is to measure how efficient our mask is against bacteria. The ASTM F2101 testing against BFE requires the efficiency to be at 95% at 3 microns. Which in layman terms, means the diameter of the mask can be 30 times bigger than the PFE requirements.
Manufacturing
Creating innovative products requires innovative technology. Our melt blown and non-woven machinery are state of the art that have been thoroughly validated and routinely inspected to ensure high performance when it comes to reliability, throughput and performance.
For the melt-blown process, the machinery generates hot streams of air at high velocity to convert the polypropylene extruding filaments to finer filaments creating the medical grade filters.
To create the breathability and protection in the inner and outer layers of the mask the non-woven machinery extrudes the polypropylene and splits the filaments in the web, creating either the high tensile layer found in the outer layer, or the comfort of the inner layer.
Quality Control
Regardless of the innovation, we ensure consistency of our product by continuously improving our quality control practices. Our factory complies to ISO 13485:2016 and follows cGMP process. Each process is routinely inspected and tested to ensure the high product reliability..We always look for customer feedback and any updates on regulation to ensure the customer’s needs are met.
● FDA Approved 510 (k) #K21172 (PMW01) ●
