Basket

FFP3 Air masks

Filtering half-mask BISAF BS3 FFP3 AIR

Medical Device 1 class

EN 149:2001+A1:2009

Directive 93/42/EEC

 

The product is entered in the register of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. 

 

It is a novelty and a unique product on the market with a comfortable shape of a medical mask, which at the same time ensures high level of filtration previously attainable only in filtering half-masks!

Properties

  • Very low breathing resistance parameters
  • Filtration ≥ 99,4% confirmed by tests with particles of 60-160 nanometres corresponding to the size of the coronavirus
  • Filtering half-mask with active and passive protection
  • Microbiologically pure
  • Bendable and flexible unlike traditional FFP3 half-masks, it is comfortable and does not obstruct breathing
  • Perfect facial fit possible due to unique clasp at the back of the head, soft foam sponge for the nose and a wire inserted in the lower part of the mask
  • Prevents glasses from fogging
  • Customizable in terms of colour and prints
  • Individually packaged product

  • It has an EU type examination certificate for compliance with 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 health care – including hospitals and Health Care Centers!
  • The device is subject to the conformity assessment procedure under 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 on essential requirements and conformity assessment procedures for medical devices Journal of Laws of 2016, item 211″

More

Gallery

Application

  • Use as an individual protection measure in workplaces and by health professionals, operating rooms, or other establishments of a similar nature
  • Use by patients to reduce the risk of spreading infection, especially in epidemic or pandemic situations
  • Use as a Personal Protective Equipment to protect the user and their environment from infectious agents in the fight against the pandemic
  • Respiratory protection against particulate or water-based aerosols (dust, smoke), liquid aerosols (mists) and bioaerosols (micro-organisms, fungi, viruses), provided that the concentration of the dispersed phase of these aerosols in the air does not exceed 20 x NDS
  • Protection of the respiratory system against harmful particles in the air, e.g.: PM10 and PM 2.5 smog particles

Instruction for proper application of the mask