Medicom SafeTouch® Free Connect Vitals Latex Glove, Natural

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 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 455-4:2009

  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 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 455-2:1995

  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 455-3:1999

  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 ISO 9001:2015

  Test results

  Service Reliability Passed

  EN ISO 9001:2015 is a globally recognized standard that specifies requirements for a quality management system (QMS), focusing on numerous aspects of quality management in organizations, aiming to enhance customer satisfaction through the effective application of the system. The 'Service Reliability' with a 'Passed' designation indicates that an organization has successfully demonstrated its ability to consistently provide services that meet customer and regulatory requirements while aiming for continual improvement. This assessment involves evaluating various elements of the QMS including service planning, execution, and monitoring, to ensure reliability and performance consistency. The practical implications for organizations that pass this aspect of the standard are significant; it establishes them as reliable providers in their industry, enhancing customer trust and satisfaction, and potentially leading to increased business and a competitive advantage.

• 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 16523-1:2015+A1:2018

  EN 16523-1:2015+A1:2018 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+A1:2018 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 ISO 374-2:2019

  EN ISO 374-2:2019 is a standard that tells how gloves should be made to protect hands from dangerous chemicals and microorganisms. It sets rules for design, materials, and testing of gloves. Possible test results include how well the gloves keep out chemicals, how long they last and how well they protect the hands. This standard specify the test methods and the performance requirements for gloves protecting against specific microorganisms and chemicals.

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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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• 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.

• 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.

• 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.

• 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.