Protective masks, 25 pcs./1 pack.
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 a comfortable medical mask shape, which also ensures a high level of filtration while allowing free breathing.
Unique 3D Fish-type design
The three-dimensional 3D Fish-type design ensures the highest comfort of use. After putting on, the mask folds into a 3D shape that allows it to be moved away from the face.
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 Oy Address: Takomotie 8, FI-00380 Helsinki, Finland Notified body no.: 0598.
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 the directive 93/42/EEC on medical devices, which allows its use both in industry and in the health service – including in hospitals and clinics! The product is subject to the conformity assessment procedure on the basis of the Act of 20 May 2010 "on medical devices, Journal of Laws of 2010, No. 107, item 679, as amended, and the Regulation of the Minister of Health of 17 February 2016, regarding essential requirements and conformity assessment procedures for medical devices, Journal of Laws of 2016, item 211"
The DOC-NFW FFP2 NR filtering half mask / medical device class I is intended for:
- Use as Personal Protective Equipment in plants, factories and by the health service, 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 factors in the fight against the pandemic.
- Sanding softwood/composite materials, rust, putty, plaster / cutting, deburring, grinding, drilling metal.
- Respiratory protection against harmful particles in the air, e.g. PM10 and PM2.5 smog particles.
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