Class I Sterile Medical Device - Regulation (EU) 2017/745

Gown suitable for high-risk surgeries involving large volumes of fluids. 

Latex Free

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Material characteristics: 

• 35 g/m² polypropylene SMMMS fabric (5 layers), resistant to fluids, bacteria and alcohol. Turquoise colour. 
• Breathable PP + PE film reinforcement fabric, 40 g/m², white colour. 
• Highly breathable, adaptable, lightweight and very durable fabric. 
• Resistant to tearing, puncturing, twisting and abrasion.
• Antistatic fabric. 
• Low particle and lint emission. 
• Silent fabric. 

Product features: 

• 100% ultrasonically heat-sealed seams, providing greater protection. 
• 8 cm synthetic elasticated cuffs, white. 
• Reinforced at the front and on the sleeves (weight of reinforced area: 75 g/m²). 
• 14 cm white nylon Velcro fastening at the neck. 
• Wrapped in white crepe paper. 
• Outer waistbands with a transfer card to ensure aseptic conditions.
• Includes two 40 x 40 cm absorbent spunlace wipes, white. 
• Dimensions when folded: 25 x 19 cm. 
• Sterilised with ethylene oxide. 

Standards: 

• EN 13795: material for surgical use as a medical device. 
• ISO EN 11810-1: laser resistance of surgical materials. Primary ignition and penetration.
• ISO EN 11810-2: Resistance of surgical materials to lasers. Secondary ignition. 
• EN 31092: Determination of physiological properties of textiles. Measurement of thermal and water vapour resistance.