Medical Device Class 1 FEATURES & BENEFITS • Protects the environment from droplets emitted by the wearer while providing protection from splashes of biological fluids. • Effective against bacterias, particles and viruses (BFE, PFE, & VFE tested). • Kolmi masks feature the exclusive Origami folding for greater comfort and a perfect fit on the wearer's face. RECOMMENDED USE Use by medical staff. Use by operating room staff in surgeries where there is a risk of splashing of biological fluids. Medical face masks may also be intended to be worn by patients and others to reduce the risk of spreading infection, particularly in epidemic or pandemic situations. Wearing the mask should not exceed 4 hours Inner layer: Outer layer: Splash barrier: Filter media: Nose piece: Ties-on: PRODUCT DETAILS Product name : Product type : Nose piece : Unit weight: Kolmi Vitals Single use, non sterile Ties-on spunbond polypropylene spunbond polypropylene spunbond polypropylene meltblown polypropylene polypropylene + metal spunbond polypropylene COMPLY WITH STANDARD EN 14683:2019+AC:2019 TEST
Open the catalog to page 1Assessment of initial microbial contamination according to standards EN 14683: 2019+AC:2019 and ISO 11737:2018+A1:2021. Additional microbiological controls: ASR, E.coli, Staphylococci, available upon request. • Meet the requirements of Regulation (EU) 2017/745 on medical devices. • Complies with applicable standards 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 storage conditions : should...
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