Standards and labels

• EN ISO 374-1:2016/A1:2018

  EN ISO 374-1:2016/A1:2018 is a standard that sets the rules for gloves that protect against dangerous chemicals and microorganisms. It says how gloves should be made, what materials should be used, and how they should be tested. Possible test results include how well the gloves keep out chemicals, how long they last and how well they protect the hands. This amendment updates the original standard with new requirements.

  Test results

  Specified Requirements Type B

• EN 455-2:2009+A2:2013

  EN 455-2:2009+A2:2013 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, freedom from protein, freedom from endotoxins, and freedom from pyrogens. Test results can include measurements of the gloves' physical properties, dimensions, packaging, freedom from holes, 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 2009 version.

  Test results

  Physical Properties Tested

  The standard EN 455-2:2009+A2:2013 focuses on the physical properties of medical gloves. The specified test result Tested in this context indicates that the physical properties of the gloves, such as strength and elasticity, have been evaluated and meet the standards set forth in the regulation. This testing ensures that gloves are safe and effective for medical purposes. The test method involves a series of assessments including tensile strength tests and elongation tests. Tensile strength tests measure the force required to break the glove material, ensuring it can withstand typical stresses encountered during use. Elongation tests, on the other hand, assess how much the glove can stretch before it breaks, which is crucial for ensuring comfort and flexibility during medical procedures. These results are vital for healthcare providers, ensuring that the gloves they use will provide adequate protection and performance during medical interventions.

• EN 455-3:2006

  EN 455-3:2006 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 1999 version.

  Test results

  Durability #,## years

  EN 455-3:2006 is part of the standards series for medical gloves for single use, focusing specifically on the requirements for biological evaluation. The 'Durability' indication, expressed as number of years, signifies the shelf life or the period during which the gloves are expected to perform effectively without degradation when stored under recommended conditions. This durability assessment involves accelerated ageing tests where gloves are exposed to elevated temperatures for a specified duration to simulate the effects of natural aging over time. The result predicts the length of time for which the gloves can be stored while maintaining their safety and performance characteristics. Gloves that meet this durability specification are crucial for healthcare providers, ensuring they have access to reliable, effective protection over an extended period, which is particularly important for inventory management and long-term supply stability in medical settings.

• 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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• 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.

• 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 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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• EN 16523-1:2015

  EN 16523-1:2015 is a European standard that defines the performance requirements and test methods for automatic towel dispensers. It sets guidelines for how much towel should come out, how high the nozzle should be, and how hard it should be to activate the dispenser. The test results should show that the dispenser meets these guidelines.

  Test results

  Permeation Contact Tested

  EN 16523-1:2015 provides the methodology for determining the resistance of materials used in protective clothing to permeation by chemicals under continuous contact. The designation 'Tested' signifies that the material has been evaluated for its ability to prevent chemical penetration over a specified duration and under certain conditions. The test method involves placing the test chemical in contact with the material and measuring the rate at which the chemical passes through to the other side, simulating exposure scenarios where chemicals might come into continuous contact with the protective gear. Materials that have undergone this testing are crucial for industries such as chemical manufacturing, healthcare, and laboratory work, where workers are exposed to hazardous substances. This certification ensures that the protective clothing provides a reliable barrier against chemical risks, enhancing safety and compliance with health and safety regulations.

• 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.

  Test results

  Micro-organisms Virus

  EN 374-5:2016 is a standard that outlines the requirements and testing methods for protective gloves designed to protect against viruses. The designation 'Virus' indicates that the gloves have passed specific tests confirming their barrier effectiveness against viruses. These tests involve assessing the glove material's resistance to penetration by blood-borne pathogens and other virus-containing fluids, using a bacteriophage as a surrogate virus due to its small size and resistance. Gloves that meet this standard are vital in healthcare settings, laboratories, and any environment where there is a risk of exposure to viral infections. They are crucial for preventing the transmission of diseases, ensuring that workers are protected when handling potentially infectious materials, thus enhancing safety and health protocols in workplaces with biological hazards.

  Micro-organisms Bacteria & Fungi

  EN 374-5:2016 specifies the requirements and test methods for protective gloves intended to protect against bacteria and fungi. The designation 'Bacteria & Fungi' indicates that the gloves have been tested and verified to provide effective barrier protection against microbial agents. The testing involves evaluating the glove's material and seams for their impermeability to microorganisms under conditions that simulate real-world use, ensuring no penetration occurs through the glove material or at the seams. Gloves certified under this standard are crucial for use in environments such as healthcare, laboratory settings, and any applications where preventing the transmission of infectious agents is essential. They help ensure the safety and hygiene of workers by providing reliable protection against the risks of bacterial and fungal contamination.

• 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 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.

• 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.

• 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.

• 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.