Description
Sterilized FFP2 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 buildup. The comfortable headband provides a secure fit without causing ear pain.
The ultimate protective solution for the highest cleanroom and hygiene standards: the Neolution®Air sterile respirator with a covered valve combines validated ethylene oxide sterilization, a filtered exhalation valve, and FFP2 filter performance in a single disposable mask, thereby providing the highest level of protection for the wearer, the environment, and the product.
The sterile respirator mask is made of high-quality polypropylene nonwoven fabric with a natural latex-free textile headband, a flexible nose clip, an exhalation valve, and a meltblown filter cover. The mask is sterilized in accordance with ISO 11135 using a validated ethylene oxide process with a proven 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, while the filtered exhalation valve simultaneously noticeably reduces moisture and heat buildup. The filtering valve cover traps germs and droplets from the wearer’s breath—a decisive advantage over open-valve masks, making this variant suitable for aseptic processes and the operating room. Each mask is delivered individually packaged to maintain sterility without compromise until use. The three-part design follows jaw movements during speech and ensures a consistently tight seal. The fabric headband does not put pressure on the ears and provides a secure fit even during prolonged wear, making it ideal for eyeglass wearers. Scientifically proven skin compatibility according to EN ISO 10993 and a passed dolomite dust retention test round out the performance profile of this unique combination.
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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