Educational Corner

> The Proper Way to Wear Durio Surgical Face Mask
Ear Loop
Tie On
> How Durio Surgical Face Mask Work?
Fluid Resistant Outer Layer (Hydrophobic)

Outer (coloured) layer of Durio mask is with hydrophobic characteristic which effectively resist fluid, droplet or splash that may contain germs and viruses that cause harm to wearers.

 

Electrostatically Charged Middle Layer (Durio Melt Blown Filter)

1) Mechanical Blocking - The filtering material has a net structure with meshes blocking particles that bigger than the mesh size.

2) Electrostatic Attraction - Further filtration of smaller particles is done by electrostatic attraction from charged filtering material.

Face mask with uncharged melt blown material can only achieve max. 40% of filtration efficiency, hence filtering material must undergo a special electrostatic charge process to enhance filtration efficiency by attraction force to small particles that escape from mechanical blocking.

 

Absorbent Inner Layer (Hydrophilic)

Soft inner layer is with hydrophilic features which effectively absorbs fluid & saliva to provide best dry comfort & minimize cross-contamination.

 
> Myth About FDA Registered, Approved & Cleared
Beware of any face mask product selling in market with packaging label of FDA logo!
 
There are 3 classification for medical device in US FDA:

a) Class I - Devices that present a low risk of harm to the user and mostly are exempt, such as non-powered breast pumps and elastic bandages.

b) Class II - Devices that present moderate-risk and require FDA “clears” for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval, such as surgical mask.

c) Class III - Device that present highest-risk and require FDA approval by providing sufficient and valid scientific evidence to ensure devices are safe and effective for their intended uses, such as mechanical heart valves and implantable infusion pumps.

In fact, surgical mask is classified as class II medical device and required to go through the Premarket Notification 510(k) process to obtain “FDA Clearance” so the manufacturer can market and sell that device in the United State. However, the device (Surgical Mask) cannot be labelled as “FDA Approved” because it did not go through the Premarket Approval process. Manufacturers are only permitted to market the device as “FDA Cleared" but cannot use the FDA logo in their marketing or labelling of the device.

Thus, beware of any face mask product selling in market with packaging label of FDA logo or "FDA Approved". And if you’re unsure if a medical device is listed with the FDA, you can search for the manufacturer in the Registration & Listing Database at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Medical device companies that are involved in the production and distribution of medical devices in United States are required to register annually with the FDA and this process is known as establishment registration.

Durio had complete registration with providing the location of medical device establishments and the devices manufactured at those establishments.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?rid=278716&fbclid=IwAR1ad4yIV80dDSSZBGl_EAqL1tqXlk_VXg_8rD6vniUvCR0aMbBHdqYmvUg
> Risk of Unqualified Face Mask
Surgical masks are more than just simple material that cover the nose and mouth; they are considered as medical device which required to meet certain specifications (ASTM F2100 / EN-14683) in order to provide sufficient protection. For this reason, counterfeit surgical masks have the potential to expose wearers to significant harm as not offer the same protection as the real product.
 
Durio have collected masks from market which labelled as Surgical / Medical grade for filtration efficiency test, shockingly the result showed that more than half of imported brands fail filtration efficiency tests. What’s more, many of these failing masks were not just a few percentage points below the standard, the worst of the worst captured even below 20% of particles which even not better than a cotton cloth.
Ear loops on some masks also broke almost immediately, some may have failed 30 out of 50 masks. Consequently, these masks are unlikely to wear for long time & the actual cost is basically higher after excluding failed quantity.
Oddly enough, there was no complaints can be made to sellers for mask performance as manufacturer details not able to be found on product packaging, this may due to manufacturers of these products do not wish to see their logos or names associated with substandard and counterfeit products.

Counterfeit products will often look like the real product and will use whichever logos, registration numbers and certifications in an attempt to look like the real product. General public is encouraged to choose the masks with clear manufacturer details & registered with MDA (Medical device authority), avoiding counterfeit products is important as this may put wearer at risk of infection.

Licensed Establishment Search
https://mdar.mda.gov.my/frontend/web/index.php?r=carian-el

Registered Medical Device Search
https://mdar.mda.gov.my/frontend/web/index.php?r=carian%2Findex&CompletedApplicationAllmdrSearch%5BglobalSearch%5D=durio

 
> Risk of Valved Respirator Face Mask
The masks with valve make breathing more comfortable and also less hot and humid for the wearer. BUT, the masks with valve only protect the people wearing them but do not stop virus droplets from escaping and infecting others.
 
This happens because these valves do not filter the air you have exhaled and the expelled air is pushed out quickly from the valve, which is actually a one-way valve. Hence, an asymptomatic carrier of coronavirus can infect others, by releasing the unfiltered exhaled air in the immediate surroundings.
Masks with valve for exhalation shouldn't be used in current coronavirus control situations as it’s only going to protect the person wearing it. In fact, these masks are designed for situations in which the wearers need to protect themselves but aren’t at risk of transmitting infection to others, for example construction workers to use to keep out dust and other particles.
It is to bring to your knowledge that the use of valved masks is destructing the purpose of wearing mask for preventing the spread of coronavirus as they don't prevent the virus from escaping out of the mask thru the valve.
 
> Surgical Face Mask & Respirator for Covid-19 Spread Control
Surgical face masks are fairly loose-fitting, disposable medical devices that prevent large droplets of bodily fluids which may contain viruses or other germs from escaping via the nose and mouth. They also protect against splashes and sprays from other people, such as those from sneezes and coughs.
 
Respirators, also called N95 masks, are designed to be tightly fit by form a perfect seal so no gap for airborne viruses to enter. The name comes from the fact that they can achieve 95% of airborne particles filtration efficiency.

For the general public, the most important consideration is comfortability which they able to wear the mask comfortably and CONSISTENTLY. N95 respirators which very high air flow resistance causing difficulty in breathing, hot & humid accumulate inside mask may detrimental to the source control measure as people may keep taking off the mask. In fact, respirators are only necessary for front liners in high risk environment which use them to protect against airborne infectious diseases, such as tuberculosis and anthrax.

 
In overall, surgical masks are generally MORE EFFECTIVE as “source control” than respirator in term of willingness of general public to wear mask CONSISTENTLY, as surgical masks may provide protection with much better comfortability & breathability.


Quick Link
Contact us now as our customer service team is happy to help and discuss it through your needs.
Privacy Policy     |     Terms of Use
Switch to Mobile Version