Description
Sterilised FFP3 mask, made in Germany. Our innovative filter material for the Neolution®Air respirator ensures low breathing resistance and particle filtration performance tested in accordance with IEST-RP-CC003.5. The comfortable headband provides a secure fit without causing ear pain.
FFP3 maximum protection, supplied sterile and with no compromise on environmental protection – the Neolution®Air combines validated ethylene oxide sterilisation with FFP3 filter performance, thereby providing the highest possible level of protection for the wearer, the environment and the product in aseptic processes and high-risk areas.
The Neolution®Air is made from high-quality polypropylene non-woven fabric, featuring a textile headband free from natural latex and a flexible nose clip. It is sterilised in accordance with ISO 11135 using a validated ethylene oxide process, with a proven bacterial reduction of at least 6 log. The high-tech FFP3-class filter material achieves an actual particle penetration rate that is many times lower than the legal requirement of max. 1% and a bacterial filtration efficiency of over 98%. It therefore protects against the most dangerous aerosols as well as bacteria and pathogens. All exhaled air is completely expelled through the filter material, making this variant the first choice wherever both environmental protection and wearer protection are required at the highest level. Each mask is supplied individually packaged to maintain sterility without compromise until use. The three-part design follows the natural movements of the jaw and ensures a constant, tight fit without the need for readjustment. The fabric headband does not put pressure on the ears and offers a secure fit even during prolonged wear, making it ideal for spectacle wearers. Scientifically proven skin compatibility in accordance with EN ISO 10993 and a passed dolomite dust retention test complete the performance profile of this exceptional disposable mask.
Examples of use:
- • Manufacture of pharmaceuticals
- • Medical procedures involving patients with infectious diseases
- • Manufacture of cytostatic drugs
- • Working in biological laboratories
- • Manufacture of medical devices
Specifications
| Category | PPE CAT III |
| Respirator Protection Class | FFP3 NR D (EN 149) |
| Medical Face Mask Protection Class | Type IIR (EN 14683) |
| Cleanroom Recommendation | Helmke-Drum Cat. I, IEST-RP-CC003.4, ISO Klasse 4 - 9, ISO 14644-1, EU GMP |
| General Standards | ISO 10993-5, ISO 10993-10, ISO 10993-23, Reg. (EU) 2016/425 |
| Material | Polypropylene (PP) |
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