Protective masks, 25 pcs./1 pack.
Unique 3D Fish-shaped design
The three-dimensional 3D Fish-shaped design ensures the highest comfort of use. Once unfolded, the mask takes on a three-dimensional shape that allows it to be moved away from the face. This design does not rest or stick to the mouth, making speaking and breathing easier.
EN 149:2001+A1:2009 Directive 93/42/EEC product entered into the register of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. A new and unique product on the market with the comfortable shape of a medical mask, which also provides a high level of filtration previously only achievable in filtering half-masks! It has an EU type examination certificate for compliance with the standard EN 149:2001+A1:2009 Personal Protective Equipment and is a class I medical device in accordance with Directive 93/42/EEC on medical devices, which allows it to be used both in industry and in the health service - including: in hospitals or clinics!
The product is subject to the conformity assessment procedure on the basis of the Act of May 20, 2010 "on medical devices, Journal of Laws of 2010, No. 107, item 679, as amended, and the Regulation of the Minister of Health of February 17, 2016, regarding essential requirements and conformity assessment procedures for medical devices, Journal of Laws of 2016, item 211"
Anti-fogging system for glasses
The upper part of the masks has sealing foam, which not only improves comfort and a perfect fit of the mask to the face, but above all prevents glasses from fogging and provides additional protection.
Adjustable two-stage fastening
The two-stage fastening allows the mask to be adjusted to any head shape and size. For additional comfort and even better personalization, you decide whether to fasten it behind the head or behind the ears, so that even long hours of use of the mask are not a problem.
The DOC-TNW FFP3 NR filtering half mask / class I medical device is intended for:
- Use as Personal Protective Equipment in plants, factories and health care, in operating rooms or other facilities of a similar nature.
- Use by patients to reduce the risk of spreading infection, especially in epidemic or pandemic situations.
- Use as Personal Protective Equipment protecting the user and their surroundings against infectious agents in the fight against the pandemic.
- Sanding hardwood (beech, oak) / wood processing with materials based on copper, chromium or arsenic / impact removal of paint / sanding cement.
- Respiratory protection against aerosols made of solid particles or water-based aerosols (dust, smoke), liquid aerosols (mists) and bioaerosols (microorganisms, fungi, viruses), provided that the concentration of the dispersed phase of these aerosols in the air does not exceed 20 x OEL.
- Respiratory protection against harmful particles in the air, e.g. smog particles PM10 and PM 2.5
Notified body for EU type examination
Notified body: AENOR INTERNACIONAL, SA (Unipersonal)Address: Génova,6, E-28004 MADRID, Spain Notified body no.: 0099.
Notified body for quality assurance of the production process
Body: SGS Fimko OyAddress: Takomotie 8, FI-00380 Helsinki, Finland Notified Body No.: 0598.
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