Kolmi Coverfeel Nitrile Glove, Blue

Standards and labels

• 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 ISO 374-5:2016

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• 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 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 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 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.

• 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.

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• 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 ISO 9001:2015

  EN ISO 9001:2015 is a standard that sets out the requirements for a quality management system (QMS). It is a set of guidelines that organizations can follow to ensure that they meet customer requirements and enhance customer satisfaction. The standard is based on the plan-do-check-act model and focuses on continuous improvement. It covers the design, development, production, installation, and servicing of products. Organizations can get certified to this standard, which means that they have been independently audited and found to meet the requirements of the standard. The certification process includes regular audits to ensure that the organization continues to meet the standard's requirements.

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• 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 374-2

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• EN 374-4

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• EN 1149-1:1995

  EN 1149-1:1995 is a European standard that defines the performance requirements for protective clothing with electrostatic properties. The standard specifies that the clothing must have a surface resistance of at least 1x10^5 ohms and a charge decay rate of less than 2 seconds. Test results can include the measurement of surface resistance and charge decay rate.

  Test results

  Surface Resistance Tested

  The EN 1149-1:1995 standard is concerned primarily with determining the surface resistance of materials used to protect against the build-up of static electricity, which could result in sparking and potential fire hazards. A test result indicating Surface Resistance Tested affirms that the fabric or surface has been evaluated for its ability to dissipate electrical charges, suggesting a level of resistance quality that makes it suitable for environments where static control is crucial. The testing method involves applying a voltage to two electrodes placed on the material surface and measuring the resistance to the flow of current. High resistance indicates that the material holds charges, while low resistance indicates good charge dissipation capabilities. This characteristic is significant in industries like electronics or petrochemicals, where preventing electrostatic discharges is vital to safety and operational reliability.

• EN 1149-2:1997

  EN 1149-2:1997 is a standard for electrical arc protection for protective clothing. It establishes performance requirements for materials and garments used in protective clothing to protect against electrical arcs. The standard includes tests for measuring the arc resistance, material flammability, and garment construction. Possible test results include pass/fail for each of these categories.

  Test results

  Performance Tested

  The EN 1149-2:1997 standard is designed to assess the electrostatic properties of protective clothing, specifically measuring the electrical resistance through a material, referred to as vertical resistance. Evaluating the test result involves determining how well the protective fabric can prevent a build-up of static electricity, which is vital for safety in environments where electrical discharges could pose a fire or explosion risk. The test method includes applying a voltage across a fabric sample while it is sandwiched between two electrodes, and the resistance is measured at both high and low voltage levels to ensure accuracy. Businesses must consider this result when selecting protective clothing for environments with potential electrical hazards, ensuring that the material has adequate resistance to prevent static electricity build-up and provide a safeguard against electrostatic discharges in volatile work conditions.

• EN 1149-3:2004

  EN 1149-3:2004 is a European standard that specifies the requirements for electrostatic dissipative (ESD) footwear. The standard defines performance requirements for material, design, and testing of ESD footwear. The footwear must be able to effectively discharge static electricity and protect the wearer from ESD. Testing includes measuring the surface resistance of the footwear material. Pass/fail results are based on the footwear meeting or not meeting the specified requirements.

  Test results

  Electrostatic Properties Tested

  The EN 1149-3:2004 standard specifies the test method for assessing the electrostatic properties of materials, specifically their ability to dissipate an electrostatic charge. The crucial test result for the standard is that a material must have a half decay time of less than 4 seconds or a shielding factor greater than 0.2 to meet the criteria stipulated by EN1149-5. This is determined through a testing process where a specimen is subjected to an induction effect that charges the material. Its ability to dissipate this charge is then measured by recording the decrease in field charge observed by a probe positioned above the test surface. The practical implications of this result for materials, especially in safety and protective clothing, are significant as it ensures that the material can quickly neutralize electrostatic charges, reducing the risk of discharge sparks in environments where flammable or explosive gases may be present.

• 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.

• 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.

• 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.