When we talk about masks, you may always think of cloth face mask or surgical face mask, or even dust masks.
However, when we talk about disposable 3 ply masks, you may immediately exclude the other two, leaving only the surgical face mask in your mind.
Indeed, in Europe, United States and most countries or regions in the world, when it comes to disposable three-layer masks, many people will consider it as medical or surgical use by default. This kind of fixed cognition has a lot to do with people’s different living habits.
In Europe, the United States and many countries in the world, people do not usually have the habit of wearing 3 ply masks. Even during the flu period, people rarely take the initiative to wear masks. Because usually people only see doctors or nurses wearing masks in hospitals or some medical and health institutions, or patients with diseases. If you wear a disposable 3 ply mask and walk on the street, people will look at you strangely and subconsciously think that you are a patient have an infectious disease or some other disease.
However, disposable 3 ply masks are popularly worn by the general public all year round in East Asian countries like China, Japan and South Korea to reduce the chance of spreading airborne diseases to others, and to prevent the breathing in of airborne dust particles created by air pollution.
What is the Definition of a Surgical Mask?
According to the defination given by Wikipedia, A surgical mask, also known as a face mask, is intended to be worn by health professionals during healthcare procedures. Surgical masks are made of a nonwoven fabric created using a melt blowing process. They came into use in the 1960s and largely replaced cloth facemasks in developed countries.
Ok, as mentioned above, the Wikipedia also took it into granted that: A surgical mask is a disposable, 3-ply face mask with a fluid-resistant middle layer of melt-blown polypropylene nonwoven. It is mainly intended for healthcare professionals during surgery and nursing and is proven to be as effective as an N95 respirator mask in preventing viral infections like influenza.
The key point is:
- What’s the main difference between a surgical mask and a cloth face mask OR a dust mask?
- What’s the main difference between a surgical mask and an ordinary 2 ply hygiene mask?
- What’s the main difference between a real surgical mask and a fake one?
For most of medical institutions and people in Europe and America, the answer are basically the same: 3-ply structure and with a middle layer of melt-blown (which plays the role of filtering).
However, from the perspective of a Chinese manufacturer, this is actually not the case in China.
There are at least 2-3 different types of disposable 3 ply masks with middle layer of melt-blown. In other words, the masks have more detailed classifications: 3 Ply Civilan Face Mask, 3 Ply Medical Use Face Mask and 3 Ply Surgical Face Mask.
What’s the difference between them?
Basically, there is no obvious difference in appearance of these three kinds of masks. Well, how to distinguish these three types of masks?
The main differences are:
- The production executive standards
- The bacterial filtration efficiency(BFE) of melt-blown
- The qualifications of manufacturer
- The medical-grade production environment (Microbial Cleanliness)
- Synthetic Blood Penetration Resistance
3 Ply Civilan/Civil-use Face Mask
In China, people use 3 ply civilian face mask as a regular daily-use hygiene device. It’s a civil grade 3 ply face mask.
It has a middle layer of melt-blown and can help to reduce the risk of droplet spread and bacterial infection. The melt-blown material acts as the filter that stops microbes from entering or exiting the mask. The pleats of mask are commonly used to allow the user to expand the mask such that it covers the area from the nose to the chin.
The production executive standard is: GB/T 32610-2016, which is a Chinese national standard for disposable 3 ply face masks civil-use.
The bacterial filtration efficiency(BFE) varies from 80% – 95%, which totally depends on the quality of melt-blown nonwoven used by manufacturers. Some poor quality 3 ply masks are produced with 80% or even lower filtration efficiency melt-blown material.
However, there are still some responsible manufacturers use 95% or even higher. Actually the BFE could surpass 98% if the manufacturer use the medical-grade melt-blown nonwoven.
During the COVID-19 pandemic, some of Chinese manufacturers who usually produce civil-use 3 ply face masks also adopted the medical-grade melt-blown nonwoven, because the demand of 3 ply masks are so huge and price is much higher, manufacturers have good profit.
Those who would like to stay on the safe side for quality and want to avoid quality complaints and troublesome by government inspections. The quality of masks was under the strong supervision of the Market Supervision Bureau and China Customs, and the punishment is very heavy, so it doesn’t make sense to take the risk that use low quality melt-blown material.
Though some manufacturers adopted the medical-grade (>98%) BFE melt-blown, the 3 ply masks could not be regarded as medical or surgical use.
The production executive standard is GB/T 32610-2016, thus, the 3 ply masks are still civil-use (according to Chinese product standards).
As mentioned above, the manufacturer has no qualification of producing medical products (need to get authorization from the China National Medical Products Administration – NMPA). They also don’t have the medical-grade production environment. The medical or surgical masks have high requirement of microbial cleanliness.
Besides, 3 ply surgical masks need to pass the test of Synthetic Blood Penetration Resistance, which is a test for surgical mask. Most of civilian masks manufacturers cannot apply for that test.
What kind of melt-blown does DISMAC use?
We “Dismac Productive Products”, always use BFE 95% melt-blown for 3 ply civilian face masks and BFE>98% melt-blown for 3 ply medical/surgical face masks.
The 3 Ply Civilian Mask is neither Medical Device nor PPE
As we know, KN95 mask, FFP2 masks and N95 masks are within the scope of PPE. They’re designed to protect the wearer against the inhalation of both droplets and particles suspended in the air.
The question is: Is the 3 ply civilian mask a PPE item since it is not suitable for medical use?
No. It is not filtering half mask to protect against particles defined in European standard or US standard.
Please notice that due to Chinese government detaied classification, there is currently no corresponding international standard for the 3 ply civilian face masks, and neither the United States nor the European Union has a corresponding standard. The 3 ply Civilian face mask is neither a Personal Protective Equipment (PPE) product nor a Medical Device.
What’s the application of 3 ply Civilian Face Masks?
It’s good choice that used for food handling, food processing, cleaning, Beauty service, Painting, Hair-dye or Laboratory.
3 Ply masks for General Medical-use or Surgical Use
The standard system for medical protective products is complex and varies in different countries and regions.
For China
“Medical masks” are classified into three categories in China, namely 3 ply general medical-use masks, 3 ply surgical masks and medical protective masks, which are subject to different standards.
The 3 ply General Medical-use Masks
The 3 ply general medical-use masks can be non-sterilized or sterilized. The 3 ply general medical-use masks are widely used in hospitals and clinics.
Chinese national standard of this type of mask is YY/T 0969-2013.
The use scenario of this mask:
I) General medical examination, nursing, general hygiene care activities, such as sanitation cleaning, liquid distribution, cleaning bed units, cleaning in hospital etc..
II) minimally invasive surgery, ophthalmology..
The 3 Ply Surgical Masks
The 3 ply surgical masks also can be non-sterilized or sterilized.
Usually the masks with Tie-on to ensure maximum fits and tightness. (3 Ply General medical-use mask is more often with elastic earloop, which also called elastic ear straps)
Due to the extra protection for blood splash and nice penetration resistance, the 3 ply surgical masks can be used in general surgical procedures and endoscopy.
Basically, the 3 ply general medical-use masks and the 3 ply surgical masks are main export products for global customers who purchased for their medical practices use.
The Medical Protective Masks
The “medical protective masks” are N95-grade medical masks, which are shell shape with headbands(not earloop). Different with the above two types of “medical masks”, the masks are not flat pleated masks.
It’s used for high-risk level in medical treatment and surgery. Just like the 3M 1860.
The Chinese executive standard is GB 19083-2010.
For US
In United States, all “medical/surgical masks” will carry a classification from the American Society of Testing and Materials (ATSM). ASTM face masks standards fall within three categories ASTM Level 1, ASTM Level 2, and ASTM Level 3. The most important difference between the levels in the degree of protection against liquid splashes or higher pressure liquid.
ASTM Level three masks offer the greatest amount of protection from liquid penetration while also have equal or better particle and bacterial blocking material than lower levels.
The manufacturers of medical/surgical masks have to get registered by FDA and Premarket Notification(510K). You could learn more from FDA website and 510K introduce.
For Europe
In European countries, all “medical masks” or “surgical masks” are supposed to meet the CE standard: EN 14683.
According to different filtering levels, the masks can be divided into three levels: TYPE I, TYPE II and Type IIR.
EN 14683 for surgical masks
A surgical mask is a medical device. Produced as per standard EN 14683, it is designed to prevent the wearer from spreading droplets in the vicinity. It also protects the wearer from droplets produced by a person directly in front of them. However, depending on the circumstances, it does not protect from inhaling the very small particles suspended in the air that potentially carry the virus. There are three different types of surgical masks*:
- Type I: bacteria filtering effectiveness > 95%.
- Type II: bacteria filtering effectiveness > 98%.
- Type IIR: bacteria filtering effectiveness > 98% and splash-resistant.
What level does DISMAC could meet?
TYPE II & Type IIR.
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