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

Suitable for high-risk surgical procedures involving large volumes of fluids. 

Latex Free

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Material characteristics: 

• 35 g/m² polypropylene SMMMS fabric, navy blue in colour, fluid- and bacteria-repellent. 
• Breathable PP + PE film reinforcement fabric, 40 g/m², white in colour. 
• Highly breathable, adaptable, lightweight and very durable fabric. 
• Resistant to tearing, puncturing, twisting and abrasion. 
• Low particle and lint emission. 
• Silent fabric. 

Product features:

• 100% ultrasonically heat-sealed seams for greater protection and safety. 
• 100% impervious to fluids and bacteria in reinforced areas (front and sleeves)
• 8 cm synthetic elasticated cuffs, white. 
• 10 cm white nylon Velcro fastening at the neck. 
• Made from 20 g/m² blue SMMMS fabric. 
• External waistbands with a transfer card to ensure aseptic conditions. 
• Includes two white spunlace absorbent wipes, measuring 30 x 40 cm. 
• Dimensions of the folded gown: 25 x 20 cm. 
• Sterilised using ethylene oxide. 

Standards: 

• EN 13795: material for surgical use as a medical device. 
• ISO EN 11810: laser resistance of surgical materials. 
• ISO EN 11135: sterilisation of products using ethylene oxide. 
• EN 556-1: Sterilisation of medical devices.