Cofra Medicshape Surgical Gown Blue
Product description
Related Content
Product Features:
- Fabric on the cuff
- Back closure with overlapping tips
- Tie card
- Ultrasound-sealed seams
- Adjustable velcro closure at the neck
- Four internal and external tie straps at the waist
- Individually wrapped in TNT with napkin in peel-open packaging
- Sterile
Technical Details:
- Fabric Composition: 100% Polypropylene- SMMS, 45 g/m²
- Quantity per box: 30 pieces
- Disposable medical device
- Class 1 according to MDD 93/42/EEC
Standards:
- EN 13795-1
- EN ISO 13485
Area of Application:
- Healthcare sector (hospitals, clinics, medical practices, nursing homes)
- Chemical industry
- Pharmaceutical industry
Defines how sleeve ends are finished and secured at the wrist, affecting weather protection, comfort, and compatibility with work gloves.
Defines the jacket's structural design, such as hooded, parka, or bomber, affecting weather protection, visibility, and functionality for specific work environments.
Indicates the jacket's primary hue, affecting visibility, practicality, and compliance with workplace safety standards or team identification.
Measured in grams per square meter (g/m²), indicating fabric density and durability. Higher numbers mean heavier, more protective materials for demanding environments.
- Medical Protection
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Standards and labels
EN 13795-1:2002 is a European standard that defines the performance requirements and test methods for surgical drapes and gowns used in medical procedures. It sets guidelines for testing the barrier properties of the material, its resistance to penetration, and its flame resistance. The standard assigns each product a classification based on its performance in the test. Test results for products under this standard will show the product's classification, as well as its barrier properties, resistance to penetration and flame resistance properties.
ISO 13485:2016 is a standard that specifies requirements for a quality management system for the design and manufacture of medical devices. It includes requirements for how companies should design, implement, maintain and improve their quality management system to ensure that their medical devices are safe and effective. Test results can include information on how well the quality management system is functioning, how well it is being followed, and how effective it is in preventing defects. The standard also includes requirements for how the company should document and record their quality management system performance and continuously improve it.
Test results
Medical Management PassedThe ISO 13485:2016 standard is specifically tailored for medical device manufacturers and aims to ensure the quality and safety of medical devices throughout their production and lifecycle. A test result of Passed in the context of the ISO 13485:2016 standard signifies that the medical device manufacturing management system under assessment has successfully met all regulatory and safety requirements stipulated in the standard. This encompasses rigorous evaluations of the manufacturer's quality management system, including processes like risk management, regulatory compliance, and effective process control. The assessment involves auditing processes such as document review, facility inspection, and staff interviews, to verify the adequacy and effectiveness of the quality management system. Meeting the ISO 13485:2016 requirements assists manufacturers in achieving and maintaining regulatory compliance and ensures that their products consistently meet user needs and applicable regulatory standards, which is crucial for entry and continued presence in global markets.
CE Marking is a label that shows a product meets certain safety and environmental standards set by the European Union. To get the CE Marking, a company must test and certify their product meets these standards. CE Marking is required for many products sold in the EU, including electronics, machinery, toys and medical devices. It helps ensure that products are safe for consumers and the environment, and allows for easy trade within the EU.
Cofra Deutschland delivery terms
Free delivery when you order more than 150,00 € from Cofra Deutschland
Supplier shipping fee 5,00 €
Brand minimum 0,00 €
65,11 €
Price per 30 pcs
2,17 € / piece
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Cofra Deutschland
Delivery time: 3 business days
Supplier shipping fee 5,00 €
Free shipping on orders over 150,00 €



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