Sempermed Supreme Surgical Gloves

Standards and labels

• 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 455-2:2009+A2:2013

  Medical gloves with the EN 455-2:2009+A2:2013 rating are tested for their physical properties, such as dimensions and strength. This ensures consistent sizing and reliable performance, giving users confidence in their protection against cross-contamination during medical 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 14971

  Medical devices with the EN 14971 rating are tested for potential hazards and associated risks throughout their entire lifecycle. This means manufacturers have systematically identified and reduced possible dangers, ensuring the products are safer for you to use.

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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.

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• 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 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.

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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 374-4:2013

  Protective gloves with the EN 374-4:2013 rating are tested for their resistance to degradation by chemicals. This measures changes in the glove material, like swelling or hardening, ensuring the glove maintains its protective qualities when exposed to hazardous substances.

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• 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.

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• EN 421:2010

  Protective gloves with the EN 421:2010 rating are tested for protection against ionizing radiation and radioactive contamination, ensuring they are liquid-proof and provide adequate shielding. This means the gloves are designed to safely protect your hands in environments where you might encounter radioactive materials or radiation.

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• 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.

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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.

• 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.

• Sterile

  Sterile refers to the absence of living microorganisms, including bacteria, viruses, fungi and spores. Sterility is achieved through various methods such as cleaning, filtration, radiation, and chemical treatments. Sterility is a requirement in many medical and laboratory settings, as well as in the production of certain food and drink products. The requirements for a sterile product or environment will depend on the specific application, but generally it should be free from any living microorganisms, it should be easy to maintain and keep clean, it should be safe for people to use, it should be able to maintain its sterility over time. Sterility is important in many medical and laboratory settings, as well as in the production of certain food and drink products to ensure that they are safe for consumption.