The manufacture and sale of protective, particle-filtering half masks requires a precise procedure that is officially checked. We have all our products tested and certified by official bodies. In order to make particle-filtering half masks such as our KARLA model available to everyone for reliable protection, a precise test is carried out according to all strict regulations. For example, for half masks like our KARLA model, a conformity assessment procedure in accordance with PPE Regulation (EU) 2016/425 must be carried out with a notified body and a type examination.
What are the requirements for FFP2 masks?
Our products also meet the requirements of the European standard EN 149:2001+A1:2009 for filtering half masks to protect against particles. The performance tests of this standard include filter penetration, flammability, breathing resistance and total inward leakage. In addition, our products have been subjected to the load test according to EN 1327, 4-7 (test method with paraffin oil). A full copy of the EN 149:2001+A1:2009 standard can be obtained from your national standardization body.
In order for a mask to be called "FFP2" and bear a CE mark, it must meet the requirements of the European standard (EN) 149:2001+A1:2009 (this corresponds to DIN EN 149:2009-08): The CE Label shows that the FFP masks have passed a successful verification procedure (conformity assessment procedure). As with medical products, we are transparently proving that all of our products meet all the requirements of the applicable laws and standards. The conformity assessment procedure includes a so-called "type examination" according to the PPE Regulation (EU) 2016/425. This test is carried out by notified bodies (e.g. TÜV, DEKRA).
This is followed by the CE marking. The CE mark bears the four-digit number of the notified body involved. The filter performance is also checked, for example. If the test criteria are met, the protective mask can be certified according to EU Regulation (EU) 2016/425. The technical and local authorities of the federal states are responsible for the lawful marketing of PPE in Germany. You can find more information on the website of the Federal Institute for Occupational Safety and Health (BAuA), e.g. B. for placing on the market and other standards.
Where do materials for the FFP2 mask come from?
We obtain materials from our certified partner companies, who manufacture all products according to strict quality standards. The following materials are used to manufacture this product:
Ear loops allow for easy adjustment to the face and head made from thermoplastic elastomer.
Nose clip for optimal fit made of steel/plastic.
Filter manufactured in layers of polypropylene.
Altogether, all materials lead to a product weight of 4.5 g.
The products do not contain any natural rubber components. Any smell of material from the masks is normal and harmless after unpacking. It goes away in no time. The expiry date is always stated on the product packaging. Before use, it should always be checked whether the product has passed its expiry date. The mask must be stored and transported in the original packaging, clean and dry in the temperature range from 5 °C to + 25 °C with a maximum humidity of 60%.
In principle, FFP masks are intended as single-use products and not for reuse. When disposing of used KARLA respirators, the regional disposal regulations must be observed.
What is the advantage of FFP2 masks?
FFP2, FFP3 and surgical masks: They are all proven to protect people from the spread of viruses. However, there is a big difference in terms of protection. FFP2 masks offer effective protection against corona viruses - provided they are worn correctly. Researchers at the Max Planck Institute in Göttingen found out in a study at the end of 2021 that for both infected and healthy people the risk of infection indoors over a short distance is only 0.1 percent, even after 20 minutes. If the mask does not fit properly, the risk of infection is around 4 percent. Surgical masks with a good fit reduce the risk to a maximum of 10 percent. In contrast to this is the result when two people meet who do not wear a mask: If in this case a healthy person were to stand three meters apart in the breathing air of an infected person for a few minutes, there is a 90 percent chance of becoming infected the explorers.
The FFP2 masks are primarily used to protect the wearer. In tests, the masks are checked to see how many aerosols and smaller droplets with an average size of 0.6 microns could get through the mask.
Their protective function is defined throughout Europe by the DIN EN 149:2009-08 standard according to strict regulations. According to this standard, the FFP2 masks must filter 94 percent of the particles. The mask contains special filter layers which are electrostatically charged. This not only traps larger particles, but also removes the much smaller (but dangerous) aerosol droplets from the inhaled and exhaled air.
What is the difference between FFP1, FFP2 and FFP3 masks?
There are FFP1, FFP2 and FFP3 masks, where the number stands for the different filter performance:
FFP1 masks filter 80% or more of the pollutants in the air we breathe
FFP2 masks filter 94% or more of pollutants and aerosols
FFP3 masks filter up to 99% of pollutants and aerosols
In order to reliably maximize the protection of wearers in different environments, we offer different models that users rely on and love to wear every day.
The FFP2 filter mask model KARLA offers effective respiratory protection in industries where workers are exposed to fine dust particles and/or non-volatile substances. The respirators are for single use. The mask should be replaced with a new, dry, clean and well-fitting mask after use, if it is wet, if it is visibly soiled or if it does not fit properly.
The shelf life of the product is three years when stored correctly. Failure to follow these instructions or misuse can significantly reduce the effectiveness of the mask. The selection of the most appropriate personal protective equipment (PPE) depends on the specific situation and should only be made by a competent person who understands the risks, working conditions and limitations of the PPE.
More detailed information on performance features and limitations can always be found on the product packaging. If in doubt, please get in touch with the relevant specialist department or a contact person at PPE Germany. Our employees are at your disposal.
What must be considered when wearing an FFP2 mask?
A protective mask must be suitable for the application and must be worn for the entire duration of the exposure. If necessary, the mask should be replaced. In addition, care should always be taken to ensure that it is seated correctly.
How to put on the mask correctly is described below:
Select the appropriate respiratory protection class
Check the durability of the mask
Follow the instructions
Check for damage
Open the mask and preform the nose clip with a finger
Pull the lower headband over your head and place it at the back of your neck
Enter with the chin, then pull over the nose
Place the upper headband above the ears
Position with the tabs
Adjust nose clip with both index fingers
Check the tight fit of the mask – adjust again if air escapes
When wearing the mask, the fit is extremely important to check the tight fit. The following steps must be carried out here:
Grasp the front of the mask with both hands without the mask slipping.
If you notice air leaking from your nose, you need to press the nose clip harder.
Check the sealing seat again.
If there is air leakage at the edges of the mask, tighten the ear straps on the head.
Check the sealing seat again.
Proper selection, training, use, and appropriate maintenance are required in order for the product to protect the wearer from airborne contaminants. Failure to properly follow the instructions for use of the respirators and/or the product to be worn at all times during exposure may result in adverse health consequences for the wearer, including disability.
It is essential that with regard to the suitability and proper use of the respirators, action is taken in accordance with the applicable local regulations and the enclosed manufacturer's instructions. The wearer must first be instructed in the correct use of the product in accordance with applicable health and safety regulations prior to use. This product does not protect the wearer from gases and vapors. Therefore, our KARLA mask should not be used in environments containing less than 19.5% oxygen.
Individual countries may also have their own guidelines for oxygen deficiency. In case of doubt, a competent person should be consulted, who will give the best possible advice on protecting the user in the individual case. Do not use the mask if the concentration of harmful substances poses an immediate threat to life and health. Facial hair in the mask area can interfere with the fit of the mask and compromise the seal.
Leave the workplace immediately if you experience difficulty breathing and/or dizziness or other symptoms. This is an important indication that the environment has a negative effect on the physical constitution. Respirator masks should be replaced and professionally disposed of if they are damaged, have high breathing resistance or at the end of a shift. We strongly advise against changing or repairing a mask. If you have explicit questions or would like basic advice on sensible and reliable protection, our employees look forward to hearing from you by phone or email.