Description
Sterilised FFP3 mask, made in Germany. Our innovative filter material for the Neolution®Air respirator ensures low breathing resistance. The covered exhalation valve prevents heat and moisture build-up. The comfortable headband provides a secure fit without causing ear pain.
The flagship product of the Neolution®Air range – the sterilised Neolution®Air with a covered valve – combines maximum FFP3 protection, a filtered exhalation valve and validated ethylene oxide sterilisation in a single-packed, disposable mask, thereby setting the highest possible standard for aseptic processes, cleanrooms and surgical applications where the focus is on the wearer, the environment and the product.
The sterilised Neolution®Air with a covered valve is made from high-quality polypropylene non-woven fabric, featuring a textile headband free from natural latex, a flexible nose clip, an exhalation valve and a filtering meltblown valve cover. It is sterilised in accordance with ISO 11135 using a validated ethylene oxide process with a proven germ 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%. The filtered exhalation valve noticeably reduces heat and moisture build-up, whilst the filtering valve cover simultaneously retains germs and droplets from the exhaled air – a protection concept that safeguards both the wearer and the environment. Each mask is supplied individually packaged to maintain sterility without compromise until the moment of use. The three-part design follows the natural movements of the jaw and ensures a constant, secure fit without the need for readjustment. The fabric headband does not put pressure on the ears and offers a secure hold 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 unique performance profile of this 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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