Since the beginning of the coronavirus pandemic, the obligation to wear face masks in many public places has put people with hearing impairments who rely on lip-reading at a huge disadvantage. The Surgical Face Mask Transparent MaXsmile from Flawa makes lip-reading possible, which significantly facilitates communication. Also for teachers, psychologists, speech therapists, counsellors, employees in retirement homes and homes for disabled people, etc. Surgical face masks (Class I medical device) are primarily used to protect other people from being exposed to any infectious droplets exhaled by the person wearing the mask. Although these masks also provide the wearer with limited protection if they fit tightly, this is not the primary purpose of their use.
By affixing the CE marking, the manufacturer declares that the product has been subjected to a conformity procedure in accordance with the applicable Regulation (EU) 2016/425 on personal protective equipment. For consumers/users, this means that the products meet the basic health and safety requirements and are suitable for their defined purpose. The CE marking serves as a passport within the EU/EEA. Accordingly, the principle of the free movement of goods applies to these products (with a few country-specific exceptions).
EU Declaration of Conformity
1 shrink bag containing 25 masks | Ref.: 105209
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Design: 3-ply non-woven fabric (outer layer, filter layer/melt-blown, inner layer)
Water-repellent spunbond non-woven fabric
Melt-blown filter (filters out coronaviruses with a diameter of approx. 0.12 microns)
Skin-friendly spunbond non-woven fabric
The following materials are used to manufacture this product:
Type II surgical face masks have a bacterial filtration efficiency of ≥ 98%
Elastic ear straps make the mask easier to put on and take off
Flat design for space-saving storage
Nose clip for optimal fit
Mouth area remains visible, which enables lip-reading
In-house production and laboratory controls
With over 100 years of experience, Flawa Consumer GmbH in Switzerland develops and produces cotton products and innovative fresh soles, primarily for the European market. In April 2020, Flawa responded to the supply shortage of protective masks at that time by setting up its own mask production facility. The expertise gained since then has transformed Flawa’s initial goal of ensuring domestic supply security into a long-term, third mainstay for the company, i.e. the production high-quality respirators; developed and produced in Switzerland.
The first batch of over 100,000 universal masks was sold out within minutes. Over several months, Flawa continuously optimised and expanded its mask production, enabling it to become the first company to produce FFP2 masks in Switzerland. It also manufactures additional mask types in the country, such as the widely used Type IIR face masks.
Flawa currently operates six plants for the production of various types of respirators, with two additional plants at the planning stage. Three of the existing plants produce FFP2 masks. The production capacity of these plants is around 500,000 FFP2 masks per week.
Flawa supplies its FFP2 masks to the Swiss federal government – other customers include retailers and foreign countries. Furthermore, bottlenecks in the procurement of raw materials due to increased demand are not an issue thanks to the company’s long-standing relationships with extremely reliable suppliers – the Flawa masks can be made ready for shipment at short notice. The filtration efficiency of the masks is regularly tested at the company’s in-house QA laboratory before they reach the market.
Dr. Alexandra Heinzelmann, www.inno-mind.de
Kundenfeedback-Nr. 300 vom 29.08.2020
Kundenfeedback-Nr. 363 vom 12.09.2020