NON-STERILE FLUID RESISTANT DISPOSABLE ISOLATION GOWN Isolation gown is fully compliant with EN 13795-1 standards. It is made from a high technology, tri-layer SMS fabric providing AAMI level II protection. It offers full protection against fluids under medium pressure conditions. KEY FEATURES . Complies with EN 13795-1:2009 [SP]. . AAMI PB70 level II protection. . These gowns are for single-use. . Side ties eliminate difficulties of tying behind the back. . Velcro closure on the neck provides a generous size for full coverage and flexibility. . They include functional cuffs constructed of a white knitted material. . Provided latex-free. . Provided non-sterile. . Knit cuffs provide a soft wrist closure for increased comfort. . Offers protection against biohazards. APPROVALS AND PROTECTION Complies with the AAMI Protective Barriers classification system and the associated minimum requirements for the liquid barrier performance of protective apparel and drapes based on industry-accepted test methods. These gowns also fulfil all essential requirements and the related rules of the European Devices Directives (MDD) and 93/42/EEC. SIZE An appropriate size garment should be selected to allow sufficient movement for the task whilst maintaining a secure fit. SIZE CHART SIZE SLEEVE LENGTH PACKAGING Each gown is individually folded and packaged into a bag. CHEST WIDTH BODY LENGTH 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. 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 26