Ansell TouchNTuff 69-210

Standards and labels

• 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 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.

  Test results

  Service Reliability Passed

• 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.

• 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.