Nitrylex One by one

Standards and labels

• 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.

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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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• 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

  Gloves and other hand protection with the EN 420 rating are tested for general safety, comfort, and harmlessness of materials. This ensures the product fits well, allows for good hand movement, and won't cause irritation or allergic reactions during use.

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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 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 1041:2008+A1:2013

  Medical devices with the EN 1041:2008+A1:2013 rating are tested for the adequacy and clarity of information supplied by the manufacturer. This ensures you receive clear, complete, and understandable instructions for safe and effective use, helping you operate the device correctly and safely.

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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 ISO 374-2:2019

  Protective gloves with the EN ISO 374-2:2019 rating are tested for their resistance to penetration by dangerous chemicals and micro-organisms. This standard checks for leaks, holes, or imperfections, ensuring the gloves form an effective barrier to keep hazardous substances from reaching your skin.

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• EN ISO 374-4:2019

  Protective gloves with the EN ISO 374-4:2019 rating are tested for their resistance to physical changes (degradation) when in continuous contact with dangerous chemicals. This means the gloves maintain their protective properties and integrity, ensuring reliable safety for the wearer.

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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.

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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.

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• 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.