Standards and labels

• EN 13485:2016

  Medical devices with the EN 13485:2016 rating are tested via a comprehensive quality management system for their safety, performance, and regulatory compliance. This ensures the products you use are reliably made and safe for your health.

  Reach out to ask about the standard test results

• EN ISO 21420:2020

  Protective gloves, mittens, and arm protectors with the EN ISO 21420:2020 rating are tested for general requirements like material safety, comfortable fit, and dexterity. This ensures the products are safe against your skin, provide a good fit, and allow for easy hand movement while you use them.

  Test results

  General Requirements Guide

  Ensures protective gloves meet general requirements for design, comfort, and safety. It guarantees the materials won't harm you, are sized correctly for better dexterity, and are constructed to be easily put on and taken off.

• EN 374-1:1995

  Gloves with the EN 374-1:1995 rating are tested for their ability to protect against dangerous chemicals and microorganisms, by measuring resistance to chemicals seeping or leaking through the material. This ensures the gloves provide a reliable barrier for user safety.

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• EN 374-5:2016

  Gloves with the EN 374-5:2016 rating are tested for resistance to penetration by bacteria and fungi, and potentially viruses. This means the gloves provide a protective barrier against microorganisms, helping to keep your hands safe from harmful biological agents.

  Test results

  Micro-organisms Bacteria & Fungi

  This product protects you from bacteria and fungi. It passed leakage tests, making it a reliable barrier when handling materials where these micro-organisms are a risk, such as in cleaning or laboratory work.

  Micro-organisms Virus

  This glove is tested to protect you from bacteria, fungi, and viruses. It provides a reliable barrier, having passed specific tests to ensure no leakage when exposed to these micro-organisms, making it suitable for handling contaminated materials.

• EN 374-2

  Gloves with the EN 374-2 rating are tested for resistance to penetration by liquids and microorganisms. This means the glove material is checked for physical defects like pinholes or leaks, ensuring it forms a barrier against harmful substances. You can trust these gloves to be waterproof and block microorganisms.

  Reach out to ask about the standard test results

• EN 16523-1:2015

  Protective clothing, gloves, and footwear materials with the EN 16523-1:2015 rating are tested for resistance to permeation by hazardous liquid chemicals, specifically how long it takes for a chemical to pass through the material. This ensures the product provides a dependable barrier, offering a measurable level of safety when handling dangerous liquids.

  Test results

  Permeation Contact Tested

  This product’s material resists liquid chemical breakthrough. It is tested for how long it takes a chemical to move through the material on a molecular level, offering protection for a specified time during continuous contact.

• EN 455-3:2015

  Medical gloves with the EN 455-3:2015 rating are tested for biological safety, including protein, endotoxin, chemical, and powder content. This ensures the gloves are safe for use, reducing risks of allergic reactions and irritation for consumers.

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• EN 455-2:2015

  Single-use medical gloves with the EN 455-2:2015 rating are tested for physical properties like dimensions and strength. This ensures gloves fit correctly and are strong enough to provide reliable protection without tearing during use.

  Test results

  Physical Properties Tested

  This product is tested for physical strength and durability to ensure reliable performance. It meets specific requirements for size, stretch, and force-at-break, providing adequate protection against cross-contamination for both the user and patient.

• EN 455-1:2020

  Medical gloves with the EN 455-1:2020 rating are tested for freedom from holes using a water tightness test. This ensures the gloves provide a reliable barrier, protecting you from cross-contamination and the spread of infections.

  Test results

  Tightness AQL #,##

  This rating indicates the glove's quality and resistance to pinholes, which is tested by filling it with water. A lower AQL number means a lower chance of defects, providing a more reliable barrier against microorganisms.

• EN 1186-7:2002

  Plastic films and sheets used in food packaging with the EN 1186-7:2002 rating are tested for overall migration of chemical substances into water-based foods. This ensures the plastic material does not transfer harmful substances into your food, protecting your health and the quality of your food.

  Reach out to ask about the standard test results

• 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.