How to buy face masks in China

I came up with the idea to write an article about face masks, the types, the EU regulations, export modalities, international standards, certificates and test reports, market overview and a few other points. Although not all is mentioned i think this article will get you on the way.

I first decided to write it in Dutch, for my home country Belgium, to give them a better insight in this matter but i changed my mind and i wrote it in English so everyone can enjoy it. The article is based on exporting masks from China to Belgium in the first place but it can be used for whole Europe if you follow the rules for that particular country you want to export to.

I tried to give an overall guide concerning the topic but it is far from complete of giving a full detailed view and background of it. The information comes from personal experience and different sources and websites regarding the matter that i compared with each other to be as accurate as possible. So lets get started!

Mask types and their classification

Disposable protective masks

This is the mask that looks exactly the same as a surgical/medical mask. It is categorized under the Chinese standard GB/T 32610-2016 and it is not very clear in which Europe nor US standards this is included. For the Europe standard some say it is the EN 14683:2019 and others say it is the EN 149:2001 + A1:2009. These both standards are for "Medical face masks" or "Respiratory protective devices" which need to fulfill certain BFE and PFE percentages on their test reports. When you search for the standard GB/T 32610-2016 on Google it does not show which Euro or US standard it corresponds with. So how is this possible?

GB/T 32610 is a "non-medical" face mask and basically used for civilians and not for doctors, nurses or other medical personal that come in contact with patients that could have been infected with a virus. The mask is used when the air quality is not optimal. The Air Quality Index (AQI) has a range of values that shows certain levels of health concerns and according to this the mask is graded from I, II or III to its Filtration Effectiveness. In grade II there is a class A and in grade III a class B, C and D all ranked to their protective effect percentage.

• Level A mask is for the condition that PM2.5 is below 500μg/m3, (serious pollution)
• Level B mask is for the condition that PM2.5 is below 350μg/m3, (severe and below pollution)
• Level C mask is for PM2.5 below 250μg/m3 and (heavy pollution and below)
• Level D mask is for PM2.5 below 150μg/m3 condition (moderate and below pollution)

*** (PM stands for particulate matter -also called particle pollution- the term for a mixture of solid particles and liquid droplets found in the air. PM2.5 refers to the atmospheric particulate matter (PM) that have a diameter of less than 2.5 micrometers, which is about 3% the diameter of a human hair. Commonly written as PM2.5 (2.5um or 2.5 micron), particles in this category are so small that they can only be seen with a microscope. The size of the coronavirus is 0.06-0.14 um or 0.06-0.14 micron).

The disposable protective mask is the cheapest of all masks and the easiest one to import and export as it is for civilian use.

Disposable medical masks

This 3-layer mask must comply with the standard YY/T0969 (China) or EN 14683 (Europe) and is a single-use medical mask, mostly in blue on the outside and white on the inside. It is suitable to use in public places that are not crowded, in an ordinary medical environment for cleaning personal or patients. The filtration efficiency for particles and bacteria are lower than medical-surgical masks and medical protective masks that are used for general protection of medical personnel like doctors and nurses.

There are also 2-layer masks in the market that are cheaper but their filtration rate is not high so it is not very effective compared with other masks. Always perform tests or check the test reports.

Surgical masks

These are the flat ones with a blue, white, green or pink color on the outside and a white color on the inside. The color itself is not of importance but the material that is being used is. Surgical masks follow the YY 0469 standard (China) or EN 14683 (Europe). There are different performance requirements and specification developed by the American Society of Testing and Materials (ASTM) which is indicated with 5 basic criteria:

• BFE (bacterial filtration efficiency) measures how well the mask filters out bacteria when challenged with a bacteria-containing aerosol. ASTM specifies testing with a droplet size of 3.0 microns containing Staph. aureus (average size 0.6-0.8 microns). In order to be called a medical/surgical mask, a minimum 95% filtration rate is required. Moderate and high protection masks have bacterial filtration rates of 98% to greater than 99%.
• PFE (particulate filtration efficiency) measures how well a mask filters sub-micron particles with the expectation that viruses will be filtered in a similar manner. The higher the percentage, the better the mask efficiency. Although testing is available using a particle size from 0.1 to 5.0 microns, ASTM F2100-07 specifies that a particle size of 0.1 micron be used. When comparing test results it is important to note the size of the test particles used, as use of a larger particle size will produce a misleading PFE rating.
• Fluid Resistance reflects the mask's ability to minimize the amount of fluid that could transfer from the outer layers through to the inner layer as the result of a splash or spray. ASTM specifies testing with synthetic blood at pressures of 80, 120, or 160 mm Hg to qualify for low, medium, or high fluid resistance. These pressures correlate to blood pressure: 80 mm Hg = venous pressure, 120 mm Hg = arterial pressure, and 160 mm Hg correlates to potential high pressures that may occur during trauma, or surgeries that include high pressure irrigation such as orthopedic procedures.
• Delta P (pressure differential) measures the air flow resistance of the mask and is an objective measure of breathability. A controlled flow of air is driven through a mask and the pressure on either side of the mask is determined. The difference in pressure is measured and divided by the surface area (cm2) of the mask segment tested. The higher the Delta P value, the harder it is for the wearer to breathe. The Delta P is measured in units of mm H2O/cm2. The ASTM standard requires that masks have a Delta P of less than 5.0, as a higher value would be considered too "hot" for general medical or surgical use. Masks with a Delta P of less than 4.0 are considered acceptable, while masks with a Delta P less than 2.0 would be considered "cool".
• Flammability: Operating rooms contain sources of oxygen and other gases used for anesthesia, and there are potential fire hazards from electrosurgical procedures such as lasers or cautery equipment. All products used within the operating room, including face masks, are tested for flame resistance. As part of ASTM F2100 testing, masks must withstand exposure to a burning flame (within a specified distance) for three seconds.

Respirator masks

N95 masks

There are several names mentioned like N95 and KN95 when it comes to respirator masks. But what do they mean? N95 is not a specific product name but refers to a certain American standard called NIOSH (National Institute of Occupational Safety and Health). 

The "N" refers to oil-resistant particles (not resistant to oil, the oil fume produced by cooking is oily particles, and the droplets produced by people speaking or coughing are not oily).

The "95" refers to the NIOSH standard of the detection condition which should have a filtration efficiency of 95% or higher. So an N95 mask is not a product name as many would think. When the product reach the N95 standard under NIOSH only then it can be called a N95 mask.

The US NIOSH 42CFR-84 standard has the highest recognition in the world.

There are 3 different filter materials classifications that ranks the percentage of the filtering efficiency of the middle layer of the mask.

Respirators are rated "N", "R" or "P":

• "N" if they are Not resistant to oil. For example, the oil fume produced by cooking is oily particulate matter, and the droplets produced by people when speaking or coughing are not oily.
• "R" if somewhat Resistant to oil. This can protect non-oily and oily suspended particles. When it is used for oily particles then the usable time should not exceed 8 hours.
• "P" if strongly resistant to oil (oil Proof). Compared with the R series, the P series is used for a relatively long time.

KN95 masks

KN is the Chinese standard that is similar to the N (NIOSH) standard of the United States. It is classified under the GB2626-206 standard and can be divided under KN or KP masks. The numbers behind the "N" or "P" represent the protection level of the mask and the larger the number the better the filter efficiency is.

"KN" refers to oil-resistant particles (not resistant to oil, the oil fume produced by cooking is oily particles, and the droplets produced by people speaking or coughing are not oily). This is same as with the "N" of the NIOSH standard.

"KP" refers to strongly resistant to oil (oil Proof). So it is suitable for preventing non-oily particles and oily particles for a relatively long time.

FFP Masks

"FFP" or Filtering Facepiece Particles is the European equivalent of the N95 and KN95 mask. It is a half-face mask that protects the chin, nose and mouth. The filtration rate, as well as the degree of leakages around the edges must meet certain standards and effectiveness tests. It protects the wearer from inhaling infectious agents or pollutants in the form of aerosols, droplets, or small solid particles. To ensure to have the highest protection it is important to use the mask in a correct way when adjusting it to the face.

• FFP1: The filtration is minimum 80% and is mainly used as a dust mask to filter dust (coal, zinc, aluminum, cement and other) that can cause lung diseases. The mask is marked with yellow elastic bands.
• FFP2: The filtration is not less than 94% and is used is various areas of the industry as it effectively stops powdered chemicals. It also protects against influenza viruses such as avian influenza or severe acute respiratory syndrome associated with the coronavirus (SARS), as well as against the bacteria of pneumonic plague and tuberculosis. The mask is marked with white or blue elastic bands.
• FFP3: The filtration is not less than 99% and is the highest protective mask which filters out very fine particles but does not offer protection against gases as nitrogen oxide. The mask is marked with red elastic bands.

BEING A NOTIFIED BODY FOR REPORTS AND CERTIFICATES

This part has a lot of controversy and takes quite some time to check if all documents and reports are true. Since the outbreak in January 2020 many new founded factories started to produce face masks in China due to the extreme shortage. Test reports and real certification, like CE and FDA, have a lot of requirements and need time to run the procedure. In the urge to export these masks, rules were bend by doing a voluntary certification by non-accredited bodies. In itself there is nothing wrong with it but most of these certificates or test reports have no value when importing the products in Europe.

China Metrology Certification or China Inspection Body and Laboratory Mandatory Approval (CMA), China National Accreditation Service for Conformity Assessment (CNAS) become names to look out for when suppliers present their test reports.

When importing to your country it is important that you know all the relevant rules and documents needed to do a flawless customs clearance (in China and your own country).

TRANSPORTATION (road and air)

When your goods are ready to export then it is time to bring them to the airport. In most cases this will happen with road freight transport to bring the cargo to your designated airport of departure. Costs regarding this depends on the terms you agreed with the supplier. Commonly used terms are ExWorks (then you are responsible for the pickup at the factory and arrange transportation by yourself including formalities), or FOB, which means Free On Board (the factory is then responsible for the transportation to the airport and formalities). So it is important you agree on this with the supplier before placing the order.

Due to the urgency these days that medical equipment, like face masks, need to be in the imported country, it is of the uttermost importance to work with a reliable and trusted airline company who can guarantee you that the supplies will get shipped and safely arrive in your country. A direct contact with them to effectively coordinate the exchange of information and the practical aspect of it is therefore not an unnecessary luxury. They can also offer the service of an agent who does the custom clearance and formalities at the airport.

CUSTOMS CLEARANCE

This has 2 parts: a customs clearance is necessary in China and in your country of import and is done by a customs clearance agent. The agent in China will handle the formalities in China and the agent in your country of import will do it there. These 2 agents are not the same nor are they connected with each other. So it is your task to find them and be aware that you choose an experienced and reliable one.

Very important is to know the export modalities in China and in the imported country as there are differences in laws and rules. Basically you need to know which documents are necessary to provide to your export-import agent for your product and this brings you back to your supplier. You need to check with them (before placing the order) if they have all certificates and reports, and that their products are up to standard. This will save you the hassle with customs in the export and import country.

As of date of 1 April 2020 and 26 April 2020, the rules to export medical equipment is tightened by the Chinese government due to certain events that happened and to ensure quality products are being exported. Below you find the rules valid on 5 April 2020. It is better to check them regular with your agent in China due to changes that can occur.

Category A - Non Medical

• Contract - Invoice - Packing list (CLP or Container Load Plan)
• Test report (CMA - CNAS) and certificate of qualification or CE (European Conformity) - Whitelisted
• Document signed by the Exporter and importer called "Joint Declaration of the Exporter and the Importer"

Category B - Medical

(there is "medical" identification and medical device product registration number)

• Contract - Invoice - Packing list (CLP or Container Load Plan)
• "Medical device business certificate" exporter
• "Medical device product export certificate at free sale" product company
• (for importer) Certificate of importer of permit medical device product of receiver
• Test report (CMA - CNAS) and certificate of qualification or CE (European Conformity) - Whitelisted
• Document signed by the Exporter and importer called "Joint Declaration of the Exporter and the Importer"

Standard Medical Mask Export company should hold:

• Medical device export record / filing
• Medical device product export business certificate of free sale

PLUS:

• For medical mask please attention on receiver country rules (CE / ISO / CFS)
• "Donation" no need permit of sales and certificate of free sale

CONCLUSION

Buying face masks in China is not as easy as it looks due to the tight export regulations, ever changing rules, product qualities and formalities to fulfill. A buyer should be cautious when entering this market and is advised to let him be assisted by a professional who is responsible of each step from production, administrative formalities, shipping and customs clearance. It can save you a lot of headaches or a financial disaster when your cargo is held in customs.

I hope this article can be helpful for you in anyway and feel free to get in touch with me if you have any questions or if this article need some updates. I would appreciate it very much if you can share this article in your circle so it can benefit more people who are active in this market.

Ronny Verdoodt