Conformity

The Livinguard PRO MASK complies with the current Corona specifications according to the federal-state resolution of January 19, 2021. It is certified as a medical face mask (EN 14683: 2019, Type I) and can be worn in retail and local transport.

Since the implementation of the increased Corona measures by the Federal Government and states, we have been receiving numerous enquiries about the admissibility of the Livinguard PRO MASK in Germany. In addition, we have been frequently made aware that customers are being denied access to retail outlets or public transport with a Livinguard PRO MASK. We apologise for any inconvenience this may cause. As in the past months, we will continue to do everything in our power to educate authorities, state governments, retailers, national and regional transport companies and other bodies to the effect that the Livinguard PRO MASK as a medical face mask according to EN 14683:2019 (Type I) and also complies with the standards for Corona Pandemic Respirators (CPA). CPA masks are considered “comparable” to FFP2 masks. This follows both from § 28b of the Infection Protection Act, which was reaffirmed by the Bundestag on 21.04.2021, and from the annex to the SARS-CoV2- Occupational Health and Safety Ordinance. The Livinguard PRO MASK therefore complies with the current Corona requirements and can continue to be worn in retail and local transport.

When asked whether, according to the new regulation of the Federal Infection Protection Act, the Corona SARS-CoV-2 pandemic respiratory protection masks (“CPA”) may also be worn in Bavaria in areas of life in which an FFP2 mask is mandatory, the Bavarian State Ministry for Health and Care also asked Email of May 3, 2021 communicated:

“for masks approved in Bavaria [there] is neither a tighten nor a relaxation compared to the federal regulation”

According to the legal justification for the new regulation of the Federal Infection Protection Act (§ 28b IfSG – see BT-Drs 19 / 28444, p. 13, 4th paragraph), the approved respiratory protection masks (FFP2 or comparable) result from the annex to the SARS-CoV2 occupational health and safety regulation. In this appendix, CPA masks are expressly classified as comparable to FFP2. The Livinguard PRO MASK complies with CPA standards. Since the same rules should apply in Bavaria as in the federal government, we are therefore of the opinion that the Livinguard PRO MASK can also be worn in the corresponding areas of life in Bavaria.

Livinguard provides documents about the certification for download. For an overview of the different mask types and certifications, see our FAQ and this infographic.

Downloads:

PRO MASK proof of conformity (mobile)

Download

PRO MASK proof of conformity (print)

Download

Hohenstein test report

Downloads:

Hohenstein test report

Download

Frequently asked questions?

Special situations call for a special type of mask

SARS-CoV-2, the coronavirus, is primarily transmitted through the air emitted by infected people when they sneeze, cough or talk. Face masks can protect against the risk of infection via this transmission mode by filtering viruses out of the air. Current guidelines on infection protection distinguish between protection against “droplets”, and protection against “airborne aerosols” (finest liquid particles and droplet nuclei; see Infection protection measures as of 14.01.2021 on RKI.de). In the meantime, a large number of different types of masks are available for private and professional use and the question arises: Which mask should I choose for protection against the coronavirus, for what purpose are the different types of masks intended and what are the legal requirements? Both the PPE Regulation (EU) 2016/425  and the Medical Device Regulation (EU) 2017/745 provide guidance in this aspect as they lay down essential requirements on health, safety and performance of the products they cover. Below we provide an overview of the different mask types used for coronavirus containment.

FFP2 / N95 / KN95

In Europe, masks specified as FFP are known as particulate respirators. They are designed as disposable masks for occupational safety, meet the requirements of the European PPE Regulation and are certified as respirators according to EN 149:2001. The filter type of an FFP mask (FFP stands for Filtering Facepiece Respirator) determines the level of protection it provides. FFP2 respirators, for instance, provide aerosol filtration of at least 94%. Another important feature of FFP2 respirators is that they provide a close fit to the face and, when used correctly, provide two-way protection, since they filter inflow and outflow. FFP2 masks are not designed for reuse and in accordance with recommendations of the DGUV (German Social Accident Insurance), should be worn for a maximum of 75 minutes without interruption and no longer than 4 hours per day. Respirator masks certified as American N95 masks and Chinese KN95 masks are similar, but not identical to European FFP2 mask standards. For the efficiency of masks with these ratings to be officially considered equivalent to FFP2 masks, they must carry the CE mark which signals that they conform to the standards of the European Union.

Surgical Masks

Surgical masks usually conform to the European Medical Device Directive under the regulation EN14683:2019 and are designed, according to the guideline of the BfArM (German Federal Institute for Drugs and Medical Devices), primarily to protect others from the transmission of droplets (third-party protection). In conformance to the standard surgical masks must provide a filter efficiency of at least 95% and are classified accordingly (Type I, Type II and Type IIR). At the same time, however, most surgical masks are usually not designed to provide a close fit around the mouth and nose, which would enable full filtering capacity. This is because the filtering performance of a face mask to protect against infections is measured not only by particle permeability but also by the breathing resistance factor. In addition to the risk of aerosol and droplet transmission for the wearer and aerosols for third parties, the medical face mask as a whole carries a risk of cross-contamination from viruses adhering to the surface of the mask. A study by Chin et al.showed that SARS-CoV-2 can still be found on the outer layer of single use surgical masks after 7 days, at room temperature. Typically single use surgical face masks should be replaced every 4 hours.

Livinguard PRO MASK 

The Livinguard PRO MASK is classified as a Medical Mask Type I and is certified according to the European Medical Device Directive under EN14683:2019. It is also compliant to standards for Corona Pandemic Respirators (CPA). CPA masks are considered “comparable” to FFP2 masks. This follows both from § 28b of the Infection Protection Act, which was reaffirmed by the Bundestag on 21.04.2021, and from the annex to the SARS-CoV2- Occupational Health and Safety Ordinance. As required by FFP2 masks, the Livinguard PRO MASK has a close fit to the face and can provide at least 95% filtration and thus effectively protect against coronavirus transmission. And there is an additional aspect: Unlike FFP2 masks, common surgical and other standard cloth masks, the Livinguard PRO MASK has been scientifically proven to destroy more than 99.9% of coronavirus (SARS-CoV-2) as proven by Free University Berlin. Prof. Dr. Gerhard Hücker, scientific expert in the field of technical hygiene at the German Central Office of the Federal States for the Health Protection of Drugs and Medical Products (Zentralstelle der Länder für den Gesundheitsschutz von Arzneimitteln und Medizinprodukten, ZLG) concludes “The Livinguard PRO MASK has all the qualities of an FFP2 mask and has also been proven to protect against the spread of the coronavirus through cross-contamination. This applies to both known variants and virus mutations too.” In addition, The Livinguard PRO MASK is reusable for 210 days and only needs to be rinsed weekly with cold water, therefore helping to reduce the enormous amount of waste associated with the use of disposable face masks.

Cloth masks

These simple face masks are intended for non-medical hygiene use to provide a barrier for droplets expelled from the nose and mouth and are not certified, nor do they provide significant protection against aerosols. Wearing cloth masks bears a significant risk of cross-contamination. Moist fabric is a breeding ground for bacteria and can carry live viruses. A survey conducted by an unbiased third party vendor on behalf of Livinguard to survey adults across the USA to better understand consumer habits and sentiments about using face masks in the age of COVID-19 revealed that a shocking 79% of Americans do not wash cloth face masks after each use and 68% reuse one-time-use masks. Face masks such as the Livinguard PRO MASK with antimicrobial properties that continuously destroy viruses and bacteria therefore appear critical to reduce the risk of cross-contamination.

More questions

All of our masks are treated with Livinguard technology and have been shown to inactivate 99.9% of SARS-CoV-2 and many other pathogens. This has been proven by various independent bodies, including a study by the FU Berlin and RWTH Aachen. Livinguard masks protect against the transmission of viruses and bacteria through direct contact (cross-contamination).

In contrast to the Livinguard STREET MASK, which has two layers, the three-layered Livinguard PRO MASK offers additional protection against the transmission of pathogens through aerosols, one of the most common transmission routes for SARS-CoV-2. Inside the Livinguard PRO MASK there is a filter medium which filters >95% of particles and aerosols.

All product packaging clearly distinguishes between the product PRO MASK or STREET MASK. The product name and other specifications are both on the sticker of the protective film and on the outer packaging. If you no longer have the product packaging, the product label on the inside shows which model it is:

PRO MASKS sold before June 2020 have a simple black label on which the size of the mask is indicated with a letter (see image A).

(Image A)

We have been selling our Livinguard STREET MASK since June 2020. We have adapted the marking on the labels accordingly. These now list the number and composition of the layers of fabric in the mask. There are three layers on the label of the Livinguard PRO MASK, namely “Outer”, “Middle” and “Inner” (see image B).

(Image B)

If two layers are specified with “Outer” and “Inner”, it is a Livinguard STREET MASK (see image C).

(Image C)

The Livinguard PRO mask is a medical mask according to EN 14683:2019. This standard defines a maximum breathing resistance of 40 or 60 Pa/cm2 for Type I and II, respectively. An FFP2 mask has a maximum breathing resistance of around 80 Pa/cm2 (when measured with the same protocol), which is considerably higher than that of a Livinguard PRO mask. In addition, the PRO mask provides the advantage that it can be worn up to 6 hours per day, while conventional FFP2 masks should be worn for a maximum of 75 minutes without interruption and no longer than 4 hours per day as per the recommendations of the DGUV (German Social Accident Insurance).

The principle underlying our technologies is the ability of polycationic surfaces to inactivate microorganisms including bacteria, viruses, and several types of fungi, and to do so without leaching.

This principle has been described in scientific literature for two decades, but its understanding and practical applications have been limited. Livinguard has leveraged this principle to invent and patent a paradigm shift from conventional approaches:

  1. Range of methods to bind a range of cationic compounds to textiles and other surfaces
  2. Portfolio of optimized chemistries to inactivate bacteria and viruses, without using traditional metal based antimicrobial agents like silver, copper, zinc, etc.
  3. Methods to combine these with other properties, such as water repellency, hydrophilicity, etc.

According to the the scientific literature, it is probable that the inactivation mechanism of viruses is based on the distortion of the protein capsid by adsorption of negatively charged proteins to the positively charged surface, finally leading to the release of non-infectious RNA.

Tests have shown that after multiple rinses or washes, the treated material (specifically textiles as tested so far) maintains its properties without leaching. This lack of leaching is the underlying reason why the antimicrobial performance is so durable as well as why it is safe for skin contact.

Please see the detailed science and technology explanation above. 

Livinguard has two primary technology platforms: Livinguard Antiviral Technology and Livinguard Antibacterial Technology. They are differentiated based on the concentration and power of the charges. The Antiviral Technology is more powerful in order to tackle smaller viruses, and is also effective against bacteria.

Livinguard Antiviral Technology has been successfully tested over the course of 5 years across different applications. Testing by the Swiss Federal Institute for NBC Protection and NSF International, among other labs, has shown inactivation of Influenza A Virus, Yellow Fever Virus, Rota Virus, Polio Virus, MS2 phage, and FR coliphage. Antiviral performance is >99.9% on average and even up to >99.9999% in some cases, with unparalleled speed of inactivation, as well as durability of performance.

Testing under the supervision of Dr. Charles Gerba at the Department of Environmental Science at the University of Arizona has recently demonstrated a >99% inactivation rate of HCoV-229E on the textiles used in Livinguard masks as per the ISO 18184 protocol. This is widely accepted as being representative of performance against SARS-CoV-2, the virus that causes the COVID-19 infection. Performance is anticipated to be even more powerful, for which further testing is ongoing.

Note that since viruses are technically not “living” organisms outside of a host, they cannot be “killed”. They are inactivated and rendered harmless.

Several facets of our technologies and products have been successfully tested extensively by a variety of international laboratories. These include the Swiss Federal Institute of NBC Protection, TÜV Sud, TÜV Rheinland, NSF International, Swiss Quality Testing Services, Product Safety Laboratories in New York, Department of Environmental Science at the University of Arizona, International Down & Feather Laboratory, and many others. It is currently under application with the US Environmental Protection Agency as the world’s first self-disinfecting textile technology.

Yes, there are chemicals involved in the process, which are compliant with regulations and impose no danger to the user. Our current recipe contains the biocide PHMB as an active ingredient. It is approved for use in textiles (see section 3) and is used in small quantities in our products, which are well below the permissible values. The primary risk of using PHMB lies in its release from the textile, otherwise known as leaching. During the treatment process of the Livinguard Technology, the PHMB is bound to the surface of the mask or textile and will not be released or leached out to any significant extent. Livinguard has passed extensive skin safety testing at Product Safety Labs in the USA as per US EPA requirements (annex 3) and in Germany as per European standards (see section 4).

PHMB (polyhexamethylene biguanide) is a polymer which has been officially approved by the Biocidal Product Committee of the European Chemicals Agency (ECHA) on 01.11.2019 under Product Type 2 (see Annex 2). Its application is approved for textiles, tissues, masks and other articles. The amount of PHMB used is so small that, even under worst-case conditions, the load of PHMB is far below the acceptable threshold level.

All of the ingredients used in our products have scientifically proven safe in use. Such tests have been conducted on the Livinguard PRO MASK in a study by the Free University of Berlin (annex 6) and RWTH Aachen University, as well as by the University of Arizona, Tucson. The results of both analyses show perfect efficacy after the washes, while the toxicity test indicates that no PHMB was released into the wash solution.

In addition, calculations according to the OECD guidelines conclude that PHMB cannot evaporate to any significant extent, and therefore adverse effects to the lungs can be excluded. Nevertheless, we conducted a study with a simulated use of a treated mask whereby the extracted air was contacted with different types of cells including lung cells (annex 4). This study confirmed that no negative effects occurr through evaporation. 

While in general we do not support testing on animals, the so called “in vivo” testing is the only reliable method to assess the safety of masks in contact with skin, as recommended by the standard ISO 10993-10 as follows: “Despite progress and considerable effort in this direction, a review of findings suggests that currently no satisfactory in vitro test has been devised to eliminate the requirement for in vivo testing.” In vivo testing on the Livinguard Technology and products has been completed and does not show any adverse effects.

This is not related to the Livinguard Technology but to the filtration capacity and breathability of the mask, which will be reduced slowly after multiple washes.

The Livinguard PRO MASK has been tested according to the ISO protocol 18184 for its antiviral effect on the Coronavirus (SARS-CoV-2) in a study by scientists of Free University of Berlin and RWTH Aachen University. This study was part of an EU project and was not sponsored by Livinguard. Prof. Charles Gerba at the University of Arizona, Tucson, conducted the same test and confirmed the efficacy for the Human Coronavirus 229E.

Wearing face masks bears a significant risk of cross-contamination, even in case of single-use. A study by Chin et al.1 showed that SARS-CoV-2 can still be found on the outer layer of surgical masks after 7 days, at room temperature. Face masks with antimicrobial properties that continuously destroy viruses and bacteria therefore appear critical to reduce the risk of cross-contamination.

Other non Livinguard masks claim to be antiviral and rely on chemicals such as benzalkonium chloride or metal based technologies such as silver, copper or zinc. Known as releasing or “leaching” technologies they are not permanently bound to the textile surface and can therefore rub off on skin, or more worryingly, be inhaled or swallowed. In addition these non durable technologies find their way into ground, sediment and surface water causing harm to the environment and aquatic life. The key “killing” component is a “chemical” force, which has the potential to force bacteria resistance and reduce benefits.

Livinguard Technology is based on polycationic technology using mechanical action to destroy viruses and bacteria and does not use any of the above referenced biocides nor work in a comparable manner. Livinguard Technology is a non-releasing technology (non leaching), which is great news for humans AND the environment, and has been tested for dermal toxicity and skin irritation.
Each square cm of a livinguard mask has about 7×1017 positive charges to inactivate negatively charged viruses and bacteria.

Genotoxicity describes the property of chemicals that damage the genetic information (DNA) within a mammal cell causing mutations, which may lead to cancer. In order to cause damage to the DNA the biocide needs to enter the mammal cell. Since the biocides are bound to the fabric it is not possible for them to be released and find their way to make contact with the mammal DNA.

No. Livinguard textiles have a positive electrostatic charge which is different to static electricity. Our treated textile has no net charge, so the electrostatic behavior is similar to other common textiles.