Standards and labels

• EN ISO 21420:2020

  Test results

  General Requirements Guide

  EN ISO 21420:2020 is a standard that outlines general requirements and guidelines for protective gloves, aiming to ensure their quality, performance, and suitability for various applications. When a product meets the requirements outlined in the General Requirements section of EN ISO 21420:2020, it signifies that the gloves comply with fundamental quality and performance criteria, including factors such as size, fit, ergonomics, and dexterity. The practical implications of this compliance are significant, as it assures users of the gloves' basic functionality and suitability for general hand protection purposes across a range of industries and applications. The test method involves evaluating various aspects of the gloves, including dimensions, construction, materials, and labeling, to ensure conformity with the specified requirements. Compliance with these general requirements enhances user confidence in the protective gloves' reliability and effectiveness, promoting workplace safety and facilitating compliance with regulatory standards.

• 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 ISO 374-5:2016

  EN ISO 374-5:2016 is a standard that sets rules for testing gloves against chemicals. The standard outlines the performance requirements for gloves to protect against specific chemicals. The test results will show if the gloves meet these requirements or not. Possible test results include information on the gloves' resistance against different chemicals and the duration of protection.

  Test results

  Micro-organisms Bacteria & Fungi

• 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 455-2:2015

  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 455-1:2020+A1:2022

  EN 455-1:2020+A1:2022 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 2020 version.

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• 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 14971:2019

  EN ISO 14971:2019 is an international standard for medical device risk management. It provides a framework for identifying, assessing, and controlling risks associated with medical devices. The standard requires that medical device manufacturers establish a risk management process and provide documentation of this process. The performance requirements include risk analysis, risk evaluation, and risk control. Possible test results include determining that the medical device is safe to use and that the risk management process is adequate.

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• EN ISO 20417:2021

  EN ISO 20417:2021 is an international standard that defines the requirements and test methods for safety and performance of electric footwarmers. This standard covers the safety, mechanical, electrical, and performance requirements for footwarmers, including thermal performance, power consumption, and temperature control. The standard also includes test methods for determining compliance with the requirements, such as temperature measurement and electrical safety testing. The test results show that the product meets the safety and performance requirements of the standard.

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• 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.

• 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.

• 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.