Description
Sterilized FFP2 respirator, Made in Germany. Our innovative filter material for the Made-in-Germany Neolution®Air Loop respirator ensures low breathing resistance and tested particle shedding in accordance with IEST-RP-CC003.5. Convenient ear loops make it easy to use.
In a class of its own: the Neolution®Air Loop sterilized FFP2 respirator combines the proven high-performance filtration of the Neolution®Air series with validated ethylene oxide sterilization, making it the top choice for cleanrooms and aseptic processes where sterility is not an option but a requirement.
The sterilized Neolution®Air Loop is made of the same high-quality polypropylene nonwoven fabric with latex-free polyester-elastane ear loops and a flexible nose clip as the proven standard version—supplemented by validated sterilization in accordance with ISO 11135 using ethylene oxide, which has been proven to ensure a bacterial reduction of at least 6 log. The high-tech filter material achieves maximum filtration efficiency with a breathing resistance well below the permissible limits—for easy, fatigue-free breathing even during prolonged wear. The three-part design follows the natural movements of the jaw and ensures a consistently tight seal without the need for readjustment; the wide ear loops do not dig in, even after hours of wear. Each mask is delivered individually packaged to maintain sterility until the moment of use. Scientifically proven skin compatibility according to EN ISO 10993 and a passed dolomite dust retention test round out the performance profile of this exceptional disposable mask.
Examples of use:
- • Aseptic processes and sterile production (GMP C, D)
- • sterile laboratory areas
- • Manufacturing or packaging of sterile medical devices
Specifications
| Category | PPE CAT III |
| Respirator Protection Class | FFP2 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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