Amabilia Safe Nitrile Diamond Glove Orange

Standards and labels

• EN ISO 9001:2015

  Products with the EN ISO 9001:2015 rating are tested for consistent quality management processes to meet customer and regulatory requirements. This means you can expect reliable products and services, as the company is committed to improving customer satisfaction.

  Test results

  Service Reliability Passed

  This product is backed by a quality management system that ensures you receive consistent and dependable service. It focuses on providing reliable support and a positive customer experience, from initial contact to post-delivery activities.

• EN ISO 14971:2019

  Medical devices, including software and diagnostic tools, with the EN ISO 14971:2019 rating are tested for how well their potential risks are identified, evaluated, and controlled throughout their entire lifespan. This rigorous process helps ensure the product is as safe as possible for you to use, with its benefits clearly outweighing any remaining small risks.

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• ISO 15223-1

  Medical devices with the ISO 15223-1 rating are tested for clear and consistent communication of important information using standardized symbols. This means you can easily understand crucial safety and usage details on your medical products, regardless of language.

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• EN ISO 20417:2021

  Medical devices and their accessories with the EN ISO 20417:2021 rating are tested for clear and complete information supplied by the manufacturer, covering identification, labeling, packaging, and instructions. This ensures you receive essential details to use the product safely and effectively, promoting patient safety and confidence.

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• EN 374-4

  Gloves with the EN 374-4 rating are tested for resistance to degradation, which is how the glove material changes after chemical contact. This ensures the gloves maintain their protective strength and barrier, keeping your hands safe from hazardous chemicals.

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• EN ISO 21420:2020

  Protective gloves with the EN ISO 21420:2020 rating are tested for general requirements, including design, construction, the absence of harmful chemicals, correct sizing, and dexterity. This ensures the gloves are safe and comfortable to wear, fit correctly, and won't cause adverse skin reactions.

  Test results

  General Requirements Guide

  Ensures gloves are designed for comfort, fit, and dexterity without using harmful materials. It covers general requirements like safe pH levels and non-toxic dyes, forming the foundation for all protective gloves.

• EN 374-1

  Protective gloves with the EN 374-1 rating are tested for their ability to resist dangerous chemicals and micro-organisms, including how well they prevent leaks, chemical breakthrough, and material degradation. This rating helps you select gloves that provide certified protection for your hands when working with hazardous substances.

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• EN 374-5

  Gloves with the EN 374-5 rating are tested for protection against microorganisms like bacteria, fungi, and viruses. This ensures the gloves act as a reliable barrier, helping to keep you safe from harmful germs and reduce the risk of infection.

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• 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.

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• EN 16523-1:2015+A1:2018

  Protective clothing, gloves, and footwear materials with the EN 16523-1:2015+A1:2018 rating are tested for resistance to permeation by hazardous liquid chemicals. This means the material provides a measured level of protection against chemicals passing through it, helping you choose safety gear that resists liquid chemical exposure.

  Test results

  Permeation Contact Tested

  This product’s material is tested for resistance against breakthrough from potentially hazardous liquid chemicals. It measures the time it takes for a chemical to move through the material, ensuring protection during continuous contact.

• EN 455-3

  Single-use medical gloves with the EN 455-3 rating are tested for biological safety, including potential chemical residues, latex proteins, and powder content. This ensures the gloves are safe for skin contact, minimizing the risk of irritation or allergic reactions for users and patients.

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• EN 455-2

  Medical gloves with the EN 455-2 rating are tested for physical properties like dimensions and strength, including force at break both before and after aging. This ensures the gloves fit correctly, are durable, and provide reliable protection against cross-contamination for both patient and user.

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• EN 455-1

  Medical gloves with the EN 455-1 rating are tested for freedom from holes to ensure they act as an effective barrier. This means the gloves reliably protect users and others from the transmission of microorganisms and contamination.

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• EN 455-4

  Medical gloves with the EN 455-4 rating are tested for their shelf life, ensuring they maintain critical properties like strength and barrier integrity over time. This means you can trust that the gloves will remain effective and safe to use until their expiration date, providing reliable protection when needed.

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• 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.

• ISO 14001

  Products from companies with the ISO 14001 rating are tested for how effectively the company manages its environmental impact, including waste reduction and resource efficiency. This means you can trust that the products are made by an organization committed to reducing its environmental footprint and operating sustainably.

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• REACH

  REACH stands for "Registration, Evaluation, Authorisation and Restriction of Chemicals" it is a regulation of the European Union that governs the registration, evaluation, authorization, and restriction of chemicals. The REACH regulation aims to ensure that the chemicals used in Europe are safe for human health and the environment. The regulation applies to all chemical substances, whether they are used in industrial processes or in everyday products such as cleaning products, paints, and cosmetics. Companies that manufacture, import or use chemicals in the EU must register the chemicals they produce or import, provide safety information and communicate the risks associated with the chemicals. This information will be used to assess the risks and determine if any further action is needed to protect human health and the environment.

• 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.