Medi-Inn Latex Gloves

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.

  Reach out to ask about the standard test results

• EN 420:2003+A1:2009

  Protective gloves with the EN 420:2003+A1:2009 rating are tested for general design, safe materials (innocuousness), water penetration, comfort, and dexterity. This ensures the gloves are safe, fit correctly, and allow you to perform tasks effectively without discomfort.

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• 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.

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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.

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• 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 455-4:2009

  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.

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• 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 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.

  Reach out to ask about the standard test results

• 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.

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• EN ISO 9001:2015

  Products from companies with the EN ISO 9001:2015 rating are tested for the company's systems for consistently providing quality products and services and meeting customer needs. This means the company is committed to consistent quality, aiming to meet your needs and improve its offerings, leading to more reliable products and better customer experience.

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• 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.