WHAT YOU SHOULD KNOW ABOUT MASKS

In most of the western world, face masks are not a common sight in public. Up until this infectious COVID-19 fell on us, there has never really been a need to wear masks. In other parts of the world, either from past epidemic experiences or poor air quality (from haze, pollen or pollution), it is a common sight to see masks used. Because of this unfamiliarity, there are undoubtedly some misinformation, misconceptions, and even misuse of masks.Here is us hoping to help clear up issues regarding masks.

If you have a question that is not answered here or have comments, let us know. We get back with you ASAP and maybe even share it here for others..

WHY ARE OUR PRODUCTS FROM CHINA?

WHAT ARE THE DIFFERENCES BETWEEN AEA MASKS FROM OTHERS?

For the most part, most people can't tell the difference between our masks and respirators against others just from the outside. Depending on the other brands, we have heard comments like our straps won't break off as easily, easier to breathe through, doesn't smell weird inside, but most can't tell the difference. If you were to cut open the masks or respirators, you would likely find more differences, like layer densities. 


Another way is if you can get test reports (authentic ones!) from the other brands. During our sourcing and even now, we receive solicitations to take on other manufacturers. Part of the process involves lab reports and, of course, pricing. We can tell you that there are indeed many dirt-cheap masks available, but they are dirt. 
We have also found some that are downright misleading, like claiming FDA/CDC approval without being on the approved list or FDA database as class 2 medical devices with verified 510k reviews. We would also see test reports that show the mask having a BFE of over 98%, but their PFE is less than 90%. This, along with other results, makes them eligible as Type IIR which is the highest grade in the European EN14683 medical mask standard, but with a PFE of less than 95%, they don't even meet Level 1 in the ASTM (US) medical mask standard. These could be accepted as medical masks in the EU but not here and not when we have a different standard. 

 

So, while our masks and respirators do look similar to others, know that there are 'more than meets the eye'. Most importantly, our surgical masks and respirators are indeed accepted by the FDA as medical-grade. This means not only AEA, but also the FDA has vetted them.   

DOES IT WORK AGAINST COVID-19?

Indeed a loaded question. Specifically to COVID-19, there are still a lot of tests to be done to really determine the effectiveness of masks, but it depends on which mask, where it is used and how it is used. If all factors are matched, then it certainly works. Otherwise, we would not have any doctors and nurses left by now.

One of if not the most critical requirement of the masks is if the masks are tested for PFE (Particulate Filtration Efficiency), which is an ASTM 2299 test that shows how much of particulate matter down to 0.1 micron is filtered. This test is tested from outside in, meaning to protect the wearer. BFE (Bacterial Filtration Efficiency) alone is quite useless against virus (COVID-19 and Flu included) and it is typically test from inside out. 

A mask or respirator that is tested to PFE >98% is what you should look for (like ours here). Most masks are not tested for PFE.

 

Here is a chart we put together that shows different masks standards and how ours fare. It applies to surgical/flat disposable masks but it is worth seeing the different standards and what we should benchmark to.

WHY SHOULD I HAVE TO WEAR A MASK? IT IS MY RIGHT TO NOT HAVE TO!

In this land of the free, it is indeed our right not to have to wear masks. However, the predominant face covering used by our fellow humans are loosely fitted masks and cloth masks. Both of which have their respective limits to protecting the user from others. So we should be more considerate of others while exercising our rights by not endangering them or giving them a hard time for not endangering us. Not to mention, it would be terrible to draw on the already strained medical resource due to simple carelessness.

Here is a nice article from a smart person that is worth the read,

https://medium.com/@Cancerwarrior/covid-19-why-we-should-all-wear-masks-there-is-new-scientific-rationale-280e08ceee71

DISPOSABLE OR REUSABLE? 

There is no doubt that a tested and certified disposable mask will perform better than a cloth mask. Aside from the poor filtration values while keeping breathability manageable, cloth mask filtration and fitting will deteriorate quickly with repeated washing. Washing is inevitable, as it is necessary after every use or at least daily. 
Hong Kong, with their tragic experience from the 2003 SARS epidemic, saw the importance of masks. Then in May 2020, they (some say as political propaganda during the Free Hong Kong unrest) distributed a new copper-infused washable mask. Unfortunately, despite all citizens receiving the masks, hardly any are wearing them. Majority masks seen worn are still disposables. It appears that the reasons include,

  • The required hand washing and line drying makes daily wear impossible,

  • Concerns of fine pieces of copper breaking off, becoming a hazard,

  • Breathability was more difficult due to the thick layers, which was found to be worse when washed.

There are many that doubt the effectiveness of copper infusion as there haven't been conclusive studies on this subject, but a major issue with cloth masks is the weight and shape. To make the cloth masks more effective, more material is used, which increases the weight. This causes the masks to drop or come loose from the face, reducing their effectiveness and, even worse, giving the user false security. 

Of course, single-use masks do add to the landfill, but we all certainly hope that the elevated risk of the pandemic won't last too long a period. Other than that, the economies of reusable and disposables are not that different, especially when values of the costlier reusables, convenience, and safety of disposables are taken into account.
Remember that if your disposable is not too wet, you could wear it at least for the whole day. We suspend ours in a food container that we wash after disposing the mask at the end of the day. When possible, we place the container with the mask inside under the sun by the office, house, or car window. 

WHAT COULD CAUSE MASKS TO FAIL?

The biggest factor for mask effectiveness is using it properly. Here are some that we noticed,

  • Mask too small for the user. Typically, to ease supply, especially in such times, masks are sold in one size. However, some may have mistakenly bought or received from some sellers, pediatric or child-sized masks, or if homemade, mismeasured. Our rule of thumb is that the sides of the masks must not be narrower than the edge of your eyes when worn.

  • Mask is not stretched past the chin and pinching around the nose bridge. Purpose made masks will have a flexible nose bridge that should be pinched against the wearer's nose to ensure a tight fit. Then the bottom of the mask should be stretched as far back under the chin as possible. You definitely don't want the nose and mouth revealed.  

  • Masks are mistakenly worn inside out. Be sure to read the instructions to identify which side is inside and which is outside. It does matter. 

  • Don't use when wet. Whether homemade or not, masks don't work well when wet.

  • Discarding properly. Don't touch the outer layer of your mask at any time, including when you are removing. For flat masks, fold the outside in and tie off with the straps. This keeps others from accidentally coming in contact with what your mask protected you against.

Here is my mask stored for later use

DO CLOTH MASKS WORK?

In short, no. Not against most bacteria, let alone a virus. There have been lab and site tests done before COVID-19 that shows reusable cloth masks put the user at significantly higher risk of respiratory illness and viruses. The biggest reasons for this are the issues of the poor filtration performance and the moisture retention of cloth masks. 
Cloth masks tend to seal to the face poorly compared to purpose-made masks and are thinner. When made thicker or added layers for filtration, they tend to retain even more moisture.  

All that being said, there are situations where a cloth mask would be fine. Here in the US, not all of us have to use elevators or be crammed on a bus, subway, or car with others, or be bunched at a pedestrian crossing, or shopping aisle. Some of us would not have any problems not getting closer than 6' to others on a whole day even when we go out like getting gas, taking a walk, etc. In such very low-risk cases, why waste a good mask when we could use a reusable mask, right? 

Of course, if you are going to get a good reusable mask, the key things to pay attention to are,

  • Contouring mask that allows it to fit around your face nicely but have some room at the mouth, like a respirator.

  • A multi-layer construction and preferably with some water resistance on the outer layer.

  • Having a nose bridge clip. 

  • Understand that when the mask is wet, it can be a highway for the bad virus.

  • Use with a filter media whenever possible.


As a rule of thumb, if you have to be close to others, particularly indoors, it will be best to have a good mask. 

Did you notice we now have reusables as well?

WHAT ABOUT THOSE COOL LOOKING POLYURETHANE OR OTHER MATERIAL MASKS WITH THE VALVE?

Cool as they may, masks with valves should not be used to curb infection. It is an opening for easier exhale but can get moist, allowing the pathogens we want to keep out get in.

KN95/FFP2 VS N95?

A respirator or filtering face respirator (FFR) is a device that snuggly seals the nose and mouth, causing air inhaled and exhaled to be efficiently filtered. Unlike surgical medical masks that may have the same material performance, because it is loose, the filtering is not as efficient.
   
Respirators like the KN95/FFP2 we offer, have the same performance as the N95. Whether in filtration down to 0.3 microns, breathability, flammability, splash resistance, both masks are almost identical. The KN95/FFP2 is also tested for leakage, whereas the N95 is not. 

The KN95/FFP2 is not made in a semi-rigid molded cup like most N95, but is cut, bonded and stitched to form a cup; it is actually more comfortable to be worn over extended periods. Particularly when fitting is not available, the molded cup forms can be brutal. 


In the current environment, N95s are hard to find. At the request of our government, these should be reserved for our healthcare professionals. KN95/FFP2, on the other hand, is quite available and costing less than half of an N95.

In other parts of the world, the general public is recognizing the performance and accessibility for these respirators and is buying for their daily use.

Typical face masks or flat masks should be worn for 2 hours or so before it is wet from exhaled moisture or uncomfortable. A respirator, on the other hand, can be worn longer since there is no contact between the mask and the mouth or nose. 


By the way, AEA will only supply KN95/FFP2 from manufacturers that have been cleared by the FDA for general and medical use. 

WHICH MASK IS RIGHT FOR ME?

  • If you are ill or show symptoms, you should not leave your house. If you have to, the KN95 L-103V would be recommended since it seals off your breathing and protects both ways.

  • If you don't go out very much or have no problems staying more than 6 feet from others for the most part, then the Level 2 or Level 3 masks are recommended.

  • If you find yourself unable to keep your distance from others or are around people that don't wear masks, then our KN95 L-103V or at least the Level 3 surgical masks is definitely recommended. Please note, the mask only protects your breathing :).

  • If you are a healthcare worker and are not issued a respirator, we do recommend our KN95 L-103V. There have been studies that indicate the virus stays airborne longer than expected and could infect. There has been a percentage of healthcare workers getting infected wearing their surgical mask. So please do so, especially if you are seeing possibly infected patients. Make sure you register as a healthcare professional so we can help the cost.

DO CLOTH MASKS WORK? (PART 2)

You have seen the short answer, here is the long answer.

Below are some studies by smart people about cloth/reusable masks vs. disposable masks (medical grade). The takeaways are,

  • We should wear masks when we can't keep the 6' distance from others,

  • Cloth masks are significantly poor in filtration performance unless you go too thick or dense where valves are needed which itself is a danger due to moisture collection,

  • Disposable (medical grade) masks are effective,

 

Now that we are at the re-opening stage, there are plenty of disposable masks available. Like those we have here, there are public masks that are medical grade to be found. So why mess with under-performing cloth masks ​that you have to carefully handle and be careful to not get too wet from talking too much? Or deal with buying and dealing with filter inserts that end up costing more than disposable masks? Then to even have to handle the "dirty" side of the mask too!

Here are some excerpts,

"Several studies, including research from my group, show that if worn properly, masks can protect people in the community from respiratory illness, especially [those] in close contact with sick people," said Dr. Raina MacIntyre. She's head of biosecurity research at the University of New South Wales in Sydney, Australia.

"I recommend disposable masks," she said. "The cloth masks used commonly in China may not be protective. We did a trial of these, compared to disposable masks, and wearers had a higher risk of infection. This may be because the cloth masks are not washed regularly and may retain moisture and become contaminated."

quoted from "Will a face mask protect you from coronavirus" By Steven Reinberg, HealthDay Reporter https://www.medicinenet.com/script/main/art.asp?articlekey=227723

"Two styles of commercially available fabric masks were the least effective with a filtration efficiency of 39-65% for PSL particles, and they performed better as the particle size increased. When the cloth masks were tested against lab-generated whole diesel particles, the filtration efficiency for three particle sizes (30, 100, and 500 nm) ranged from 15% to 57%. Standard N95 mask performance was used as a control to compare the results with cloth masks, and our results suggest that cloth masks are only marginally beneficial in protecting individuals from particles<2.5 μm. Compared with cloth masks, disposable surgical masks are more effective in reducing particulate exposure." 

taken from "Evaluating the efficacy of cloth facemasks in reducing particulate matter exposure." by Shakya KMNoyes AKallin RPeltier RE.

https://www.ncbi.nlm.nih.gov/pubmed/27531371

Study title "A cluster randomised trial of cloth masks compared with medical masks in healthcare workers" by,

C Raina MacIntyre, Holly Seale, Tham Chi Dung, Nguyen Tran Hien, Phan Thi Nga, Abrar Ahmad Chughtai, Bayzidur Rahman, Dominic E Dwyer, Quanyi Wang

Results The rates of all infection outcomes were highest in the cloth mask arm, with the rate of ILI statistically significantly higher in the cloth mask arm (relative risk (RR)=13.00, 95% CI 1.69 to 100.07) compared with the medical mask arm. Cloth masks also had significantly higher rates of ILI compared with the control arm. An analysis by mask use showed ILI (RR=6.64, 95% CI 1.45 to 28.65) and laboratory-confirmed virus (RR=1.72, 95% CI 1.01 to 2.94) were significantly higher in the cloth masks group compared with the medical masks group. Penetration of cloth masks by particles was almost 97% and medical masks 44%.

Conclusions This study is the first RCT of cloth masks, and the results caution against the use of cloth masks. This is an important finding to inform occupational health and safety. Moisture retention, reuse of cloth masks and poor filtration may result in increased risk of infection. Further research is needed to inform the widespread use of cloth masks globally. However, as a precautionary measure, cloth masks should not be recommended for HCWs, particularly in high-risk situations, and guidelines need to be updated.

https://bmjopen.bmj.com/content/5/4/e006577

In summary, the dangers of a cloth mask are

  • Lack of filtration, unless filter media is used and fitting is tight,

  • Moisture retention, multi layers will help but will still eventually need to be replaced,

  • Improper handling, washing of hands before and after handling

Keep these factors in mind when using reusable mask.

Yes, our products are from China. This is simply because there are currently no US manufacturers that have the capacity to produce medical-grade masks or respirators for the general public; for years, the US manufacturers have either reduced their domestic production or outright outsourced to China. This is the reason for the shortage when the pandemic started (although this topic is worthy of a separate page later). Meanwhile, with no other countries able to export or produce these masks, we can only look to reputable and established manufacturers in China.

The challenge was to ensure that the products were, in fact, of the quality we required. After obtaining the test reports from reputable 3rd party labs, we further narrowed down potential manufacturers and products to only accepted, tested, and certified ones by the FDA. The Level 2 and 3 surgical masks were not as tricky since the FDA has an excellent database and code system where registered companies can be looked up. However, this database also has some shady companies that registered with the FDA, yet their products are not registered appropriately. In doing so, they can claim to have FDA registration, but with further investigation, their products are not what they claim to be. On the other hand, our Level 2 and Level 3 were registered way before the pandemic and approved under the FXX surgical mask code, which means the FDA has reviewed and accepted the mask as a Class 2 medical device with a valid 510k premarket review.

 

The respirator was trickier because the pandemic triggered hundreds of new KN95 manufacturers, but most of these have no business producing respirators to save lives -- even worse, some have knowingly sold inferior quality products. Since these respirators are the only available medical N95 alternatives, the FDA has started regulating and reviewing them. As a result, we have to continually follow the FDA's updates on what they are approving for medical use. Our manufacturer, Harley, being a NIOSH certified manufacturer has been on that short list since day one.  

 

Finally, aside from identifying the right manufacturers and products, we also have to deal directly with the manufacturer and not through a 3rd party entity like a broker or agent, etc. This way, there is no one involved that has no vested interest.

AEA has worked and dealt with both US and foreign companies, and bad, unscrupulous folks are everywhere. What we have chosen to do is put in our due diligence and trust that given the right circumstances, no one wants to do bad. 

If you are interested in reviewing the test reports or be directed to the relevant FDA pages to see what we have discussed, shoot us an email or chat. 

 

(615) 219-9893

4245 Carrolton Drive, Franklin, Tennessee, USA.

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