FAQ - Frequently Asked Questions
On this page you will find frequently asked questions related to Lifa Air's products, manufacturing, and the selection and use of the protector.
What is the difference between respirators and medical face masks?
Respirator protects the user from air pollution, dust, bacteria and viruses. If it does not have an exhalation valve, it also protects the environment from possible splashes by the user and also from airborne diseases that they may carry. Respiratory protection is classified as personal protective equipment.
The main purpose of the medical face masks is to protect other people from the user's exhalation and possible splashes. At the same time, it also provides some protection for the user against similar air pollutants. Medical face masks are classified as medical devices.
What is the Disposable mask?
The disposable mask can be of any shape and material. This category also includes fabric masks and homemade masks. The folk mask is classified as a general consumer good.
How are protectors classified according to filtration efficiency and what standard do they follow?
The standard for medical face masks is EN 14683. The protectors are classified into Type I, Type II and Type IIR classes mainly according to filtration efficiency and splash protection. Type I minimum filtration efficiency is ≥95%. Type II and type IIR filtration efficiency is ≥98%. In addition, the Type IIR is splash-proof.
The standard for respirators is EN 149. The standard tests several different properties, but the best known is the filtration efficiency, according to which protectors are classified into the following categories: FFP1, FFP2 and FFP3. The classifications are uniform across the EU and are known by the acronym FFP, or Filtering Face Piece. Of these, FFP1 is the lowest official protection class and FFP3 the highest, respectively. The minimum filtration efficiencies are FFP1 ≥80%, FFP2 ≥94% and FFP3 ≥99%.
Disposable masks, or folk masks, have no mandatory standard, no regulation, and no official requirements for filterability, for example.
There are a lot of technical requirements associated with protectors. Which authority in Finland monitors compliance with them?
Respiratory protection: Ministry of Social Affairs and Health (professional use) and Tukes (consumer use)
Medical Face Masks: Fimea
Folk Masks: Tukes
What are the standards of respirators here in Finland and in the EU and how do they differ from their counterparts in China or the USA, for example? What is the most significant difference?
Respirators sold in Finland and Europe must be CE marked and must meet the requirements of Personal Protection Regulation 2016/425 in all respects. The products must also pass tests in accordance with EN 149: 2001 as well as official type approvals.
In Europe, the United States and China, the standards of respirators are quite close to each other. The test protocols for the different regions differ somewhat, for example, slightly different sizes and compositions of test particles are used to determine the filtration efficiency. The European protection class FFP2 corresponds to the American protection class N95 and the Chinese protection class KN95. Correspondingly, the protection class FFP3 corresponds to the American protection class N100 and the Chinese protection class KN99. In the United States, the regulatory authority is the FDA, and in China, the local equivalent. Respiratory protective equipment for sale must always be type-approved in each market in which the protective equipment is sold.
How do I choose the right product for the purpose?
Medical and disposable face masks
The Type IIR Medical face mask is a medical device and should always be CE marked. The product is mainly used in healthcare in procedures and surgeries where there is a risk of blood splashes or contamination of the patient's care staff. The product is used e.g. in hospitals. The breathing resistance of the product should be <60 (Pa / cm2). The packaging bears the marking IIR (R = splash-proof), the CE marking and EN 14683.
The Type II Medical face mask is otherwise the same product as the Type IIR, but without the splash protection feature and with lower respiratory resistance (<40 Pa / cm2). Marking II, CE marking and EN 14683 on the packaging.
The Type I Medical face mask is a medical device and should always be CE marked. The product is mainly used in healthcare (not in procedures or surgeries), the pharmaceutical industry, the electronics industry and consumer use. The breathing resistance of the product should be <40 (Pa / cm2). Marking I, CE marking and EN 14683 on the packaging.
The disposable mask is a common consumer product, also called a folk mask. The product is not intended for healthcare use. The product must not be CE marked or otherwise classified in accordance with Tukes guidelines. Lifa Air mouth-nose protection is suitable for consumer use in situations where it is not possible to keep a distance. The product goes through a similar high-quality manufacturing process as Lifa Air's other protectors.
Respirators are personal protective equipment. Their purpose is to protect the user of the product from airborne diseases, contaminants and other harmful particles. Versions without a valve also protect others from user splashes and airborne diseases (particle size less than 5µm). When using respirators, the respirator must fit snugly on the user's face. Respiratory protective devices must bear the CE marking and the four-digit identification number of the notified quality controller of the protective equipment, as well as a reference to standard EN 149.
Who should use these protectors? In what situations?
Protective equipment is normally worn by those who need it for their work, such as healthcare professionals and other occupational groups who are exposed to compounds and particles that are hazardous to health at work. Now, during a Covid pandemic, it is always important for the average citizen to follow the current official guidelines and recommendations, which can be found, for example, on THL website.
What is the right way to use protectors?
The product packaging contains instructions for use, which are important to follow carefully. As a general guideline, the guards should always be touched only with clean and disinfected hands. The shield should be placed on the face with the colored side facing out, the metal nasal thread shaped like the nose and so that it covers the nose, mouth and chin.
How do you ensure that your products are high quality and safe to use?
In all situations, our operations are guided by our values: quality, scientificity, safety, transparency and proactivity. We have very precise criteria for all the materials we use in our products. We only use carefully selected known and reliable material producers. We constantly monitor the quality of both the raw material and the finished products.
Do you do post-processing of the products?
The products are manufactured in clean rooms and are not post-processed. They are always packaged clean directly from the production line to the packaging. No post-treatment is required, as the products have been tested to be microbiologically pure. Therefore, like chemically after-treated products, they do not cause any side effects to the user. This is extremely important to us and part of a high-quality production process.
How do you control the quality of the products?
Each batch of raw materials and production is tested separately in Lifa Air's own laboratory. We have built our own unique testing system in Finland, which allows us to ensure the filtration efficiency of the products. This always ensures the functionality of the product and the homogeneity of the batches.
The features of our products are world-class, even internationally; they are always compliant, their certifications are up to date and traceable. It is extremely important to us that all our products meet current standards and are manufactured in accordance with Good Manufacturing Practice (GMP), which is typical of medical devices and personal protective equipment.
How is the filtration efficiency of products ensured?
We manufacture the most important part of the products, ie the filter material, at our own factory in Finland. This always ensures the required filtration efficiency and guarantees the availability of the material. Each batch is tested in Lifa Air's own laboratory.
Are Lifa Air products suitable for people with allergies?
Our products are also safe for people with allergies, children and special groups because we do not use hazardous ingredients or chemicals in our production. The materials used in all products have been extensively tested, e.g. By ECHA according to the SVCH list. The materials have therefore been inspected for Substances of Very High Concern (SVCH) identified by the European Chemicals Agency (210 substances in total).
We have commissioned separate tests to ensure the skin-friendliness of the end products. Medical face masks have been tested to the following ISO standards:
EN ISO 10993-5:2009 (Biological evaluation of medical devices)
EN ISO 10993-10:2013 (Test for irritation and sensitization)
Due to their protective effectiveness and technical properties, our products are suitable for use not only in social and health care, but also in pharmacies and government operations.
What products does Lifa Air manufacture in Finland? And when did manufacturing begin?
The Finnish factory started operations in April 2020. Our range currently includes the Type I, Type II and Type IIR medical face mask and the FFP2 and FFP3 respirator. In addition, we manufacture a disposable mask (folk mask) if needed.
Who are Lifa Air's largest customers?
The majority of our manufacturing capacity is used by the Security of Supply Center, which then distributes the equipment nationwide as needed. In addition, we prioritize the needs of the healthcare sector.
What products does Lifa Air currently manufacture in China? How long have you been making them in China? Where have they been delivered in the past?
Lifa Air currently manufactures KN95 and EN149 compliant FFP2 respirators and air purifiers in China. We have been manufacturing them in China for several years. We have previously supplied our respirators e.g. to China and Southeast Asia and we supply air purifiers from our Chinese factory around the world. We have sold respirators in China and Asia for both professional and consumer use, as respirators are commonly used there due to air pollution. Naturally, our Chinese manufacturing plant also has precise quality control criteria.
We do not currently manufacture medical face masks in China.
What kind of manufacturing / approval process is involved in the guards?
We manufacture both medical face masks and respirators in Finland. Medical face masks are subject to the requirements of the Medical Devices Directive. Respiratory protection is subject to the requirements of Personal Protection Regulation 2016/425 in accordance with the EU Directive. Products must pass standard testing and type approvals.
All our products are manufactured in accordance with the Good Manufacturing Practice (GMP) typical of medical devices. The purpose of GMP is to ensure that manufactured products, such as medical devices that have a direct impact on human health, are produced in reliable environments and conditions. GMP defines and monitors the quality and reliability of the production site, environment, equipment and production process, personnel and raw material.
Where is Lifa Air's factory located?
We understand that there is great interest in the factory, but we are not currently disclosing the location of the factory as our team needs peace of mind.
Which parties finance the construction of your Finnish factory? Under what conditions?
We have received a loan from Business Finland to implement the project. We have not applied for a direct grant.
What does nationality and the Key Flag sign mean to you?
Domestic manufacturing guarantees Finland's security of supply and brings work and livelihood. We are proud that we are creating a new industry in Finland and at the same time we directly and indirectly employ hundreds of people.
With the Covid pandemic, there is a strong demand for domestic protective equipment manufacturing and we want to serve Finnish society with stable production and high-quality products. The domestic supply chain employs locally and brings with it many benefits.
Lifa Air's face masks and respirators have been awarded the Avainlippu label, which tells about Finnish work. With it, we want to send a message about activities that ensure well-being in Finland. Our packaging materials also come from Finland.
The international market for face masks and respirators has grown strongly with the pandemic. What are the implications of this?
Long and multi-generational supply chains can pose challenges for buyers when goods are procured from afar and often in large batches. Products, labels and certificates do not necessarily meet the requirements of the EU region and Finland. Issues of responsibility for countries of manufacture and manufacturers can also be difficult to resolve.
A domestic product is a safe and responsible choice. A short supply chain is a transparent and environmentally friendly choice for transportation.
I am a consumer customer, where do I buy products?
You can conveniently order Lifa Air products from our online store: www.lifamasks.shop
Our products are also available from well-stocked pharmacies, grocery stores and Maskimaatti vending machines.
Maskimaatti vending machines can be found in the largest shopping malls around the country.
I am a business customer, how do I order larger quantities?
Please contact us for business sales (pallet orders) at: email@example.com
I buy products for sale in pharmacies
The following retailers and online stores sell to pharmacies:
Where can I ask for more information or leave feedback?
You can inquire about our products or leave feedback through this form.
Are Lifa Air's products also sold abroad?
Our goal is to build a long-term viable commercial company that serves the healthcare needs of Finland and the Nordic countries. Our goal is to manufacture more than 100 million respirators and medical face masks in Finland annually.
In the future, we will also manufacture protective equipment that is critical for national security on the international market, as long as the situation caused by the coronavirus normalizes in Finland. In the first phase, however, our goal is to meet domestic demand. When the situation normalizes, we will start exporting and thus ensure the viability of the industry in Finland also in the future.
What is the Maskimaatti?
The Maskimaatti is Finland's first mask vending machine. With the help of the Maskimaatti, we want to meet the demand and availability of face masks in places where there are a lot of people moving around, such as at public transport hubs. Different sizes of protectors are available. The first Maskimaatti was opened in the Kamppi Shopping Center in Helsinki and now they can also be found in other large shopping centers throughout Finland.
Where can I get more information about the Maskimaatti?
Responsible for operating the Maskimaatti: Toygroup Oy, p. +358 45 134 2364.