Standards and labels

• EN 455-3:1999

  EN 455-3:1999 is a European standard for disposable medical gloves. It sets out the definition, performance requirements and test methods for this type of gloves. The standard includes requirements for physical properties, dimensions, packaging, freedom from holes and freedom from powder. Test results can include measurements of the gloves' physical properties, dimensions, packaging, freedom from holes and freedom from powder.

  Test results

  Biological Evaluation Tested

  The EN 455-3:1999 standard evaluates the biological safety of medical gloves for single use. It focuses on tests that determine acceptable levels of endotoxins, protein content to minimize allergic reactions, and leachable substances which could have harmful effects. Essentially, the test results from EN 455-3:1999 determine if the tested gloves release any potential allergens or toxic chemicals that could harm users, ensuring product safety in regards to biological factors.

• EN 455-2:2009

  EN 455-2:2009 is a European standard for disposable medical gloves. It sets out the definition, performance requirements and test methods for this type of gloves. The standard includes requirements for physical properties, dimensions, packaging, freedom from holes, freedom from powder and freedom from protein. Test results can include measurements of the gloves' physical properties, dimensions, packaging, freedom from holes, freedom from powder and freedom from protein. This version of the standard includes some changes and updates from the 2000 version.

  Test results

  Physical Properties Tested

  EN 455-2:2009 is a European Standard specifically designed for determining the physical properties of medical gloves. The result showing that gloves have been tested under EN 455-2:2009 indicates that the gloves meet the criteria for physical performance as prescribed by this standard. The testing method, as laid out in EN 455-2:2009, includes assessments of the gloves’ tensile strength and elongation before and after aging, force at break, and dimensions, among other properties. This rigorous testing ensures that the medical gloves will perform reliably under typical conditions of use. Compliance with this standard is critical for gloves used in medical settings, as it confirms the product's capability to withstand practical use without failure, ensuring safety and effectiveness for both healthcare providers and patients.

• EN 455-1:1993

  EN 455-1:1993 is a European standard for disposable medical gloves. It sets out the definition, performance requirements and test methods for this type of gloves. The standard includes requirements for freedom from holes, tensile strength, elongation, and packaging. Test results can include measurements of the gloves' freedom from holes, tensile strength, elongation and packaging.

  Test results

  Tightness AQL #,##

  EN 455-1:1993 sets the standards for medical gloves for single use, focusing on freedom from holes and ensuring glove integrity. The 'Tightness' test result, indicated by an Acceptable Quality Level (AQL) value, measures the quality level acceptable for the pinhole rate in glove batches. A lower AQL value, such as 1.5, typically used in medical settings, signifies a higher level of quality control where fewer gloves with defects are allowed. The testing for this standard involves randomly selecting gloves from a batch and filling them with water to check for leaks. Gloves that pass this test at a certain AQL value are deemed safe for use in medical and surgical procedures, where maintaining a sterile environment is crucial to prevent contamination and infection. This certification ensures that users can rely on the protective barrier of the gloves against pathogens and other contaminants.

• EN 455-4:2009

  EN 455-4:2009 is a European standard for disposable medical gloves. It sets out the definition, performance requirements and test methods for this type of gloves. The standard includes requirements for freedom from holes, dimensions, packaging, freedom from powder, freedom from protein and freedom from endotoxins. Test results can include measurements of the gloves' freedom from holes, dimensions, packaging, freedom from powder, freedom from protein and freedom from endotoxins.

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• ISO 13485:2016

  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 Passed

  The 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.

• MD Label

  MD stands for "Medical Device." It refers to any instruments, apparatus, machines, implants, or other similar or related articles that are intended to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability. In Europe, a MD Label is a special label that must be on all Medical Devices that are sold or used in the European Union (EU). The label must include information about the product, such as the name of the manufacturer, the intended use of the product and CE mark. To be able to sell or use a Medical Device in the EU, the device must meet certain standards and requirements set by the European Union and notified body.

• Food Safe

  Food safe refers to the safety of food products that are used or consumed by people. In Europe, food safety is regulated by the European Union (EU) and the European Food Safety Authority (EFSA). These organizations set standards and requirements for food products to ensure they are safe to eat. To be considered "food safe" in Europe, a product must meet these standards and be free of harmful substances. This includes being free of harmful bacteria, pesticides, and other contaminants. Food products that do not meet these standards cannot be sold or used in the EU.