We are unique because...
FDA Approved as Class 2 medical device.
Tested to ASTM Level 2 and Level 3.
PFE (0.1 microns) & BFE over 98%.
High outer layer fluid resistance.
Perfect for daily wear in low to moderate risk situations.
ASTM2100 Level 3
The highest level of Surgical masks
DISPOSABLE MEDICAL-GRADE MASKS
ASTM Level 2 and Level 3 for everyone!
As we move towards the re-opening of our country, it is time for our public to have access to real quality masks as well. There has been minimal standards guidance for disposable or any public mask from the FDA or CDC. So it is left to the consumer to learn up and make informed decisions that could end up costing materially and health.
The disposables AEA offers are, first of all, entirely usable by the healthcare industry since the FDA has approved the product under the FXX code. Most of the disposables found in the public market won't have the FXX code despite claiming FDA or CE certified or registered. Some may even have FDA logos on their packaging, which is illegal.
Unlike most that claim to have a BFE >95%, ours are actually tested under the EN14683 as Type IIR having a BFE (Bacterial Filtration Efficiency) of > 98% and splash resistance (moderate for Level 2 and high for Level 3), and they are also tested to the ASTM 2100-19 as Level 2 and 3, which includes PFE (Particulate Filtration Efficiency to 0.1micron) of > 98% and a flammability resistance of class 1.
Please note that PFE is critical as it is tested from outside of the mask, which means it is to protect the users. Most 3-ply disposables you currently find flooding the market, including those from some reputable big box stores are not tested for PFE and Splash resistance.
ASTM 2100 also requires breathability to be tested. A real ASTM 2100-19 tested mask actually breathes easier than most think. Ask our healthcare heroes, they wear them for much longer than we would.
AEA's masks are genuinely multipurpose face mask, designed to the highest barrier performance for civilian and surgery use, approved by the FDA with the 510k review.
As shown in studies, a good fit is essential to effective protection for the wearer and others. Basically, the tighter, the better, especially at the nose bridge and cheeks.
Here is additional information on flat surgical masks. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-and-surgical-masks-face-masks#s2
There are currently massive amounts of disposable masks being dumped into the market at low prices. However, without standards being required, most of these do not meet US standards. Having CE, FDA logos or BFE >95% are not indicative of their standards. Be wary of these!
Our Level 2 masks are made by Brun Medical and our new Level 3 (4-ply) by Copioumed International, both out of China. For those concerned about these products from China, please see why we chose them for this product here.
These ASTM Level 2 and Level 3 masks are made specially for the better protection of the general public.
In stock and warehoused in the USA
In case you missed it, here is a blog post we did regarding the differences of our Level 2 mask vs. another 3-ply masks.
HERE IS A STANDARDS COMPARISON CHART
A few points to highlight when looking at this chart:
Most masks sold in the US for public use are not tested to any of these standards.
Other masks that you find claiming BFE >95% may not be tested under the US medical mask standards.
The ASTM standard is geared toward the safety of the wearer and others since PFE is required.
There is a big difference between ASTM Level 1 to Level 2 but just splash resistance difference between Level 2 and Level 3.
Chinese and European medical mask standards are more lenient when compared to the US medical mask standards.
Our Level 2 masks offered here are indeed ideal for general public safety since it is tested to the ASTM Level 2 and the EU standard as Type IIR. This means >98% on BFE and PFE, good breathability, high enough fluid resistance, flame resistant, and low microbial contamination.
New to our product line is the Copious Level 3 masks. These are 4-ply with similar perfomance as the Level 2 except with the maximum splash resistance from the 4th layer and better breathability. This is as high as surgical masks protection go.
How to possibly improve your flat mask or make it stay on younger children better? Or for the ladies, keeping the mask from messing with your lower eye liners?
What if you don't have a respirator but are going into a situation that makes wish you have one?
This video is a simple technique to improve the fitting of your loose-fitting mask. If used with a good medical-grade mask like those we offer, you would technically get a mask similar to an N95 or KN95 or FFP2 respirator performance. The surgical mask and respirator's biggest difference is that surgical masks are not tight-fitting, failing to seal to the face. This significantly reduces the efficiency of the mask's filtering function of the air breathed in.
With this hack, your flat mask can be improved. Give it a try!
Disclaimer: Not laboratory tested to be effective; may not work on all head sizes; Might get a little uncomfortable.