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 455-2:2015

  EN 455-2:2015 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 EN 455-2:2015 standard pertains to the physical properties of medical gloves, primarily focusing on ensuring they meet required levels of durability and performance under typical usage conditions. The designation that the physical properties were Tested under this standard implies that the gloves have undergone specific testing protocols to measure their tensile strength and elasticity and have been found compliant with predefined standards. The test method for physical properties under EN 455-2:2015 involves simulating conditions to mimic normal use and stresses that gloves would experience, such as stretching, which reveals both the elasticity and tensile strength of the material. Gloves undergoing these tests are stretched until they can stretch no further without breaking, and these results indicate whether the gloves are suitable for practical use in medical environments, offering users confidence in the durability and integrity of the gloves under operational conditions.

• 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.

• EN 455-3:2015

  EN 455-3:2015 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 2006 version.

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• EN 455-1:2000

  EN 455-1:2000 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 and freedom from protein. Test results can include measurements of the gloves' freedom from holes, tensile strength, elongation, packaging, freedom from powder and freedom from protein. This version of the standard includes some changes and updates from the 1993 version.

  Test results

  Tightness AQL #,##

  EN 455-1:2000 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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• EN ISO 21420:2020

  EN ISO 21420:2020 is a European standard that sets out the general requirements for hand protection, including comfort, fit, and dexterity.

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• EN ISO 374-4:2019

  EN ISO 374-4:2019 is a standard that sets the rules for gloves that protect against dangerous chemicals and microorganisms. It tells 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 standard focus on the use of gloves against specific microorganisms and chemicals, and specifies the performance requirements and test methods for gloves protecting against viral penetration.

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• 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.