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 420:2003+A1:2009

  EN 420:2003+A1:2009 is a European standard that sets out the general requirements for hand protection, including comfort, fit, and dexterity. Performance requirements include resistance to abrasion, cut, tear, puncture, and impact. Test results should show the gloves meet these requirements.

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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.

• EN 374-4:2013

  EN 374-4:2013 is a European standard for gloves that protect against microorganisms. It sets rules for how the gloves should protect against microorganisms and how to test if they meet the standards. Gloves that pass the tests can have a label that says they meet the standard. The test results can be pass or fail for each test that checks the gloves resistance to microorganisms.

  Test results

  Degradation Tested

  The standard EN 374-4:2013 pertains to the determination of degradation by chemicals for protective gloves. Degradation is assessed based on the change in physical properties of the glove material after contact with a chemical. Specifically, a result indicating degradation provides a measure of the glove's deterioration in terms of features like tensile strength and elongation when exposed to specific chemicals, gauged through physical tests such as elongation and tensile tests. The test method involves exposing the glove material to the chemical over a determined period, followed by mechanical testing to compare the pre and post-exposure properties. This result is crucial in determining the glove's suitability for use with specific chemicals, as degradation can significantly reduce its protective effectiveness, potentially endangering the user. Hence, understanding and adhering to this standard helps in the selection of appropriate protective gloves for specific chemical exposure scenarios, ensuring user safety and compliance with health and safety regulations.

• EN ISO 374-1:2016

  EN ISO 374-1:2016 is a standard that defines the performance requirements for gloves that protect against chemicals and microorganisms. The standard specifies the design, materials, and testing requirements for gloves to protect against chemicals and microorganisms. Possible test results include measurements of the gloves' permeation resistance, degradation, and penetration. It also includes the safety and functionality requirements for gloves.

  Test results

  Specified Requirements Type B

• EN 374-5:2016

  EN 374-5:2016 is a European standard for gloves that protect against microorganisms, specifically gloves that are used for medical and dental procedures. It sets rules for how the gloves should protect against microorganisms and how to test if they meet the standards. Gloves that pass the tests can have a label that says they meet the standard. The test results can be pass or fail for each test that checks the gloves resistance to microorganisms.

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• EN 455-1:2020

  EN 455-1:2020 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, packaging, freedom from powder, freedom from protein, freedom from endotoxins, and freedom from pyrogens. Test results can include measurements of the gloves' freedom from holes, tensile strength, elongation, packaging, freedom from powder, freedom from protein, freedom from endotoxins and freedom from pyrogens. This version of the standard includes some changes and updates from the 2000 version.

  Test results

  Tightness AQL #,##

  EN 455-1:2020 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 374-2:2014

  EN 374-2:2014 is a European standard that defines the performance requirements and test methods for chemical protective gloves against microorganisms. It specifies the minimum requirements for gloves to protect against microorganisms. The standard includes test methods for resistance to penetration by microorganisms and possible test results include pass/fail for each requirement.

  Test results

  Penetration Resistance Tested

  EN 374-2:2014 is an European Standard that specifies the requirements and test methods for evaluating the resistance of gloves to penetration by chemicals and/or microorganisms. In the test a glove is assessed for its capacity to resist penetration by micro-organisms or chemicals through pores, pinholes, or other imperfections. The test method involves inflating the glove with air or filling it with water and then examining it for leaks. This standard is important for ensuring that protective gloves do not allow harmful substances to reach the skin, thereby providing safety in chemical and biological environments.

• EN 455-2:1995

  EN 455-2:1995 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, and packaging. Test results can include measurements of the gloves' physical properties, dimensions, and packaging.

  Test results

  Physical Properties Tested

  The European standard EN 455-2:1995 deals with the requirements and testing for physical properties of medical gloves. This test evaluates the physical strength and durability of gloves to ensure they are safe for use in medical settings. The specified test result from EN 455-2:1995, such as tensile strength and elongation, indicates how much force a glove can withstand before breaking and how much it can stretch, respectively. The test methods typically involve applying a force to a glove material to measure its tensile strength and elongation. These measured properties help classify gloves' suitability for various medical tasks, providing critical information for users regarding the gloves' resilience and flexibility. Thus, manufacturers and procurement professionals can use this metric to assess the quality and appropriateness of medical gloves for specific applications, ensuring safety and compliance with EU regulations in medical environments.

• 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.

  Reach out to ask about the standard test results

• CE Marking

  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.

• 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.

• PPE Category 3

  PPE stands for "personal protective equipment." PPE Category 3 refers to equipment that is complex and provide the highest level of protection such as powered respirators, SCBA, and full body suits. In Europe, PPE Category 3 must meet certain safety standards set by the European Union, which means that it must be designed and manufactured to protect the user without causing harm. Companies that make or sell PPE must prove that it meets these standards. They also must have a quality management system in place, have to be audited regularly by a notified body and have to have a technical documentation.

• 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.