Kolmi® Technical Data Sheet Medical face mask with earloops - Type IIR - Visor - Kolmi® SoftexMedical 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. • Transparent polyester visor with anti-fog treatment on both sides. To ensure its protection, the outer face is protected by a film to be removed before use. This helps to ensure perfect vision for the user. • Use by operating room staff in surgeries where there is a risk of splashing of biological fluids. Item Color PRODUCT DETAILS Product name : Product type : Fasteners : Nose piece : Unit weight : Kolmi® Softex Type IIR Single use, non sterile Earloops Polypropylene and steel Polyester 90 x 175 mm 8 g 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.

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 Item Outer case Inner box Bld de la chanterie | 49124 Saint Barthelemy d'Anjou - France