COATS® Disposable Gloves, Dawn Blue

Standards and labels

• 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.

  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 ISO 374-1:2016/A1:2018

  Protective gloves with the EN ISO 374-1:2016/A1:2018 rating are tested for resistance against dangerous chemical penetration, permeation, and degradation. This means the gloves are proven to protect your hands from hazardous substances and indicate how long they can withstand contact with specific chemicals.

  Test results

  Specified Requirements Type B

  This glove provides protection against chemical splashes, resisting permeation for at least 30 minutes for a minimum of three specific chemicals. It is suitable for tasks involving handling certain chemicals where moderate contact is expected.

• EN ISO 374-5:2016

  Gloves with the EN ISO 374-5:2016 rating are tested for resistance to penetration by microorganisms like bacteria, fungi, and viruses. This ensures the gloves provide a protective barrier, helping to shield you from harmful germs and potential infections.

  Test results

  Micro-organisms Bacteria & Fungi

  This product provides a protective barrier against bacteria and fungi. It has passed a penetration resistance test to ensure it prevents these micro-organisms from getting through, making it suitable for cleaning and handling contaminated materials.

• 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+A1:2022

  Medical gloves for single use with the EN 455-1:2020+A1:2022 rating are tested for freedom from holes and leakage. This ensures the gloves provide a reliable barrier, minimizing the risk of contamination for your safety and protection.

  Reach out to ask about the standard test results

• EN 455-4:2009

  Single-use medical gloves with the EN 455-4:2009 rating are tested for their shelf life, ensuring they maintain properties like strength and barrier integrity over time. This means the gloves will remain effective and safe, providing reliable protection against infections until their expiration date when stored correctly.

  Reach out to ask about the standard test results

• 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.

  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.

• 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.