Ansell MicroFlex MK XTRA 93-862

Standards and labels

• 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 421:2010

  EN 421:2010 is a European standard that specifies requirements and test methods for gloves to protect against ionizing radiation and radioactive contamination. The standard is applicable to gloves offering protection to the hand and various parts of the arm and shoulder. It applies also to gloves to be mounted in permanent containment enclosures.

  Test results

  Radiation & Contamination Tested

  EN 421:2010 is a European standard designed to address radiation protection for protective clothing. Its purpose is to ensure that protective clothing worn in environments where there is a risk of radiation exposure provides adequate protection to the wearer. One of the critical aspects tested under this standard is the resistance of the protective clothing to penetration by radioactive contamination. This test result signifies the ability of the clothing to prevent radioactive particles from reaching the wearer's skin, thereby minimizing the risk of contamination and radiation exposure. The test method involves exposing the protective clothing to a specific level of radioactive contamination and then assessing whether any penetration occurs. Practical implications of this result for the product category include ensuring that protective clothing meets stringent safety standards, thereby safeguarding the health and well-being of individuals working in radiation-prone environments such as nuclear facilities or medical facilities handling radioactive materials.

• EN ISO 374-5:2016

  Test results

  Micro-organisms Bacteria & Fungi

  EN ISO 374-5:2016 is a standard that defines the requirements for gloves to protect against dangerous chemicals and micro-organisms, including bacteria and fungi. The test results indicating protection against Bacteria & Fungi confirm that the gloves have effectively passed the necessary evaluations to guard against these types of micro-organisms. The test method used assesses the glove's resistance to penetration and permeation by micro-organisms. The glove material undergoes specific challenges designed to ensure that pathogens such as bacteria and fungi cannot penetrate or permeate through the material under standard testing conditions. Practical implications of these results include assurance that gloves certified under this standard provide health professionals and others exposed to biohazards with a reliable barrier against potential infections caused by bacteria and fungi, which is crucial for both healthcare settings and lab environments.

• EN ISO 374-1:2016

  Test results

  Specified Requirements Type B

  The EN ISO 374-1:2016 standard specifies requirements for gloves intended to protect against chemicals and micro-organisms. A glove that achieves a Type B test result in this standard offers resistance to at least three chemicals, with a breakthrough time of at least 30 minutes for each chemical tested. This test involves subjecting the gloves to chemicals and measuring the time it takes for the chemicals to penetrate through the material. Practical implications for this test result entail selecting gloves categorized under Type B for environments where exposure to specific hazardous chemicals for durations not exceeding 30 minutes is anticipated. This makes the gloves suitable for certain chemical handling tasks within specified limits, assuring a protective barrier during the exposure period.

• 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.

• 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.

• 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.