Standards and labels

• ISO 13485:2016

  Medical devices with the ISO 13485:2016 rating are tested for a quality management system that ensures consistent safety, quality, and regulatory compliance throughout their lifecycle. This provides assurance that the product is reliably produced to high international standards for patient use.

  Test results

  Medical Management Passed

  This product was made under a quality management system that ensures consistent design, production, and distribution. This focuses on the safety, performance, and regulatory compliance of medical devices throughout their entire lifecycle, from design to disposal.

• 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 ISO 374-1:2016

  Gloves with the EN ISO 374-1:2016 rating are tested for resistance against dangerous chemicals and microorganisms, including penetration, permeation, and degradation. This means you can choose gloves designed to protect your hands from specific chemical hazards, ensuring safer use in various tasks.

  Reach out to ask about the standard test results

• 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 455-1:2000

  Medical gloves with the EN 455-1:2000 rating are tested for freedom from holes, primarily using a water leak test. This ensures the gloves provide a reliable, intact barrier, protecting both the user and patient from cross-contamination during medical procedures.

  Test results

  Tightness AQL #,##

  This product meets a quality standard for medical gloves, ensuring a very low probability of pinholes. This provides a reliable barrier against bacteria and viruses, making it suitable for tasks requiring protection from cross-contamination.

• EN 1186-6:2002

  Plastic films and sheets used for food packaging with the EN 1186-6:2002 rating are tested for overall migration, measuring how much of the plastic's components transfer into fatty foods like oils. This ensures that the material is safe for food contact and does not contaminate your food.

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• EN 1186-8:2002

  Plastic containers and other fillable articles designed for fatty foods with the EN 1186-8:2002 rating are tested to measure how much material can transfer from the plastic into the food. This ensures these products are safe for storing fatty foods without leaching harmful substances, protecting your health.

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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

• 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.