TGA-M-007 3 PLY Disposable Face Mask-Designed
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3 PLY DISPOSABLE FACE MASK Disposable face mask is composed of ear loops, nose clip and ear loops, made of PP non-woven fabric, PP melt-blown, and non-woven Fabric. Plays the role of isolation and protection through filtration, the fixed nose clip enhance the protection,of the mouth and nose. 3 PLY Disposable Face Mask Type 2R KEY FEATURES . Tested and CE approved to EN 14683+AC 2019 Medical face mask-Requirements and test methods and ISO13485:2016 Medical Devices- Quality management systems . Bacterial filtration Efficiency ( BFE ) >98. . Splash Resistance Pressure 16. . Differential Pressure (PA/cm2) <60. . Microbial cleanless (cfu/g) <30 . Comfort ear loops allow for easy donning and doffing. . Provided latex-free and plexiglass. . Contains no components made from natural rubber latex. APPROVALS AND PROTECTION 3 ply Face Masks fulfils the requirements for medical devices. CE approved under Medical Devices Regulation, 93/42/EEC STORAGE AND DISPOSAL . Store in dry and clean conditions in original packaging, away from direct sunlight, sources of high temperature, and solvent vapours. . Expected shelf life is 3 years from the date of manufacture when stored as stated. . Replace garment if damaged, heavily contaminated of in accordance with local work practice or regulations. . Handle and dispose of contaminated garments with care and in accordance with applicable regulations. WARNING AND LIMITATIONS Make sure that the product is suitable for the application and fitted correctly. Product must never be altered or modified. Final determination as to the suitability of these products for a particular situation is the employer’s responsibility. This information is subject to revision at any time. PACKAGING 50 pcs per box. 40 boxes per carton. INTENDED USE . For use in clinical and laboratory settings. . Intended to protect from the transfer of microorganisms and bodily fluids in low or minimal risk patient isolation situations. . Not intended for high risk surgical procedures, or where the risk of contamination is high. . Typical applications may include blood, bodily fluids and environmentally controlled clean room applications. TGA MEDİKAL VE DIŞ TİCARET A.Ş. Sultan Selim Mah. Behçet Sok. Büyükdere İş Mrk. No:4 D:5 Kağıthane/İstanbul-TURKEY T: +90 212 264