Kolmi® Technical Data Sheet Medical face mask with earloops - Type IIR - Without nose piece - Kolmi® Softex Medical Device Class IFEATURES & BENEFITS • Protects the environment from droplets emitted by the wearer while providing protection from splashes of biological fluids. • Effective against bacteria, particles and viruses o (tested for BFE, PFE, & VFE). • Kolmi® masks feature the exclusive Origami fold and Smile welding for enhanced comfort and a perfect fit to the wearer's face. • For maximum comfort, the inner layer is designed with Softex technology, which minimizes facial irritation and does not wear out during prolonged use, even in contact with a beard. • Without nose piece. • Recommended for use by patients undergoing MRI, CT scan or X-ray. • May also be suitable for use in prison or psychiatric settings where the metal nose piece may be considered dangerous. Item Color PRODUCT DETAILS Product name : Product type : Fasteners : Unit weight : Kolmi® Softex Type IIR CERTIFICATIONS & STANDARDS Meet the requirements of Regulation (EU) 2017/745 on medical devices. Comply with the applicable standards EN 14683:2019 + AC: 2019. Manufacturing site: ISO 9001 and ISO 13485 certification. 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.

Medical face mask with earloops - Type IIR - Without nose piece - Kolmi® Softex Medical Device Class I EN 14683:2019+AC:2019 The mask must be used on intact skin only. The reuse or extended use may lead to infection or cross-contamination. Please refer to your national legislation on the subject of disposal of this product once it has been used. Normal conditions of conversation & storage: not to be exposed to moisture and sunlight, must be stored at room temperature. Shelf life of the product: 5 years. LOGISTICS Outer case Spec. Inner box spec. Item weight Packaging Item Outer case Inner box...