Standards and labels

• 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.

  Tightness AQL #,##

• 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.

  Physical Properties Tested

• 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.

  Service Reliability Passed

• 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.

  Medical Management Passed

• 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.

  Reach out to ask about the standard test results

• 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.

  Reach out to ask about the standard test results

• EN 420:2003+A1:2009

  EN 420:2003+A1:2009 is a European standard that sets out the general requirements for hand protection, including comfort, fit, and dexterity. Performance requirements include resistance to abrasion, cut, tear, puncture, and impact. Test results should show the gloves meet these requirements.

  Reach out to ask about the standard test results

• 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.

  Specified Requirements Type C

• EN 374-2

  Reach out to ask about the standard test results

• EN 374-4

  Reach out to ask about the standard test results

• 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.

  Micro-organisms Bacteria & Fungi

  Micro-organisms Virus

• 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.