FEATURES AND BENEFITS • Filtering half mask, efficiency class FFP1 NR D developed to protect against solid and liquid aerosols and particles. • Type IIR certified, it protects the environment against droplets emitted by the wearer and it protects him from potential body fluids splashes. • Knitted headloops ultrasonically welded for an optimal comfort. • Thanks to its shape, and the use of soft materials, the mask fits perfectly to the face to limit inward leakage. • This mask is hypoallergenic and has been dermatologically tested*. *Tested on a panel of 32 people by an accredited laboratory Recommended use • Use in dusty environment • To prevent against risky infectious diseases • Intended to be worn by patients and others to reduce the risk of spreading infection, especially in epidemic or pandemic situations. PRODUCT DETAILS Product name : Product type : Nose piece : Unit wieght: Kolmi Oxygen Single use, non sterile Headloops Polypropylene and metal White 50 units 8 g The Mass Balance approach: made up of 70% recycled material, our FFP Mass Balance range reduces the consumption of polypropylene from fossil resources. This chain of custody allows the recycled material added at the beginning of the production process of the mask components to be attributed to the finished product. This approach, which uses a chemical recycling process using heat, allows used polypropylene to be returned to the monomer state and thus retain the same characteristics as virgin polypropylene. Therefore, the performances of our Mass Balance FFP range are strictly similar to our standard range

MICROBIOLOGICAL INFORMATION • Assessment of initial microbial contamination according to standards EN 14683: 2019+AC:2019 & ISO 11737: 2018+A1:2021. • Additional microbiological controls: ASR, E.coli, Staphylococci, available upon request. CERTIFICATIONS & STANDARDS • In accordance with requirements of Reg (EU) 2017/745 on medical devices. • In accordance with requirements of Reg (EU) 2016/425 on personal protective equipment. • In accordance with requirements of the Swiss Ordonnance on medical device (ODim) from July 1st 2020. • Comply with the applicable standards EN 14683:2019 and EN 149:2001+A1:2009....

The device should only be used on intact skin only. Their reuse or prolonged use may result in infection or cross-contamination. After use, comply with the current national regulations for disposing of the device. STORAGE CONDITIONS Normal storage conditions: should not be exposed to moisture and sunlight, must be stored at room temperature. Product shelf life: 5 years. PACKAGING MARKING Outer case spec. Item Outer Case Bld de la chanterie | 49124 Saint Barthelemy d'Anjou - France