Kolmi® Technical Data Sheet Medical face mask with earloops - Type IIRMedical Device Class I Kolmi® Softex FEATURES & BENEFITS • Protects the environment from droplets emitted by the wearer while ensuring protection against splashes of biological fluids. • Effective against bacteria, particles, and viruses (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. • Clinically tested, wearing the Kolmi® Softex Type IIR medical mask reduces symptoms of seasonal allergies (rhinitis, nasal congestion, conjunctivitis, cough, asthma, sneezing, headaches). It significantly improves the quality of life for individuals allergic to pollen (pilot clinical study Alyatec 2022). • Use by operating room personnel for surgeries with a risk of exposure to biological fluids. • Medical masks may also be intended to be worn by patients and other individuals to reduce the risk of spreading infections, particularly in outbreak or pandemic situations. Product name : Product type : Fasteners : Nose piece : Unit weight : Kolmi® Softex Type IIR Single use, non sterile Earloops Item Color 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 Medical Device Class I 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. MedicalDevice LOGISTICS Outer case Spec. Inner box spec. weight Packaging Item Outer case Inner box Bld de la chanterie | 49124 Saint Barthelemy d'Anjou...