Pearl Black nitrile 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.

  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.

• 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 455-1:2020

  Medical gloves with the EN 455-1:2020 rating are tested for freedom from holes using a water tightness test. This ensures the gloves provide a reliable barrier, protecting you from cross-contamination and the spread of infections.

  Test results

  Tightness AQL #,##

  This rating indicates the glove's quality and resistance to pinholes, which is tested by filling it with water. A lower AQL number means a lower chance of defects, providing a more reliable barrier against microorganisms.

• EN 420:2003

  Protective gloves with the EN 420:2003 rating are tested for their general safety, proper fit, and user dexterity. This ensures the gloves themselves won't cause harm, fit comfortably, and allow you to perform tasks effectively.

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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 1186-1:2002

  Plastic food containers and materials with the EN 1186-1:2002 rating are tested for the total amount of substances that could transfer from the plastic into your food. This helps ensure the product is safe for food contact and won't contaminate your meals.

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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.

  Test results

  Service Reliability Passed

  This certification shows a commitment to quality and consistency. It ensures the company's processes are managed to deliver reliable, effective service and a better customer experience from start to finish.

• EN ISO 374-1:2016

  Gloves with the EN ISO 374-1:2016 rating are tested for resistance against dangerous chemicals and microorganisms, including penetration, permeation, and degradation. This means you can choose gloves designed to protect your hands from specific chemical hazards, ensuring safer use in various tasks.

  Test results

  Specified Requirements Type C

  Provides splash protection against at least one specific chemical for more than 10 minutes. These gloves are suitable for tasks involving limited or short-duration contact with specified low-risk chemicals.

• 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.

  Reach out to ask about the standard test results

• EN 374-2:2014

  Gloves with the EN 374-2:2014 rating are tested for their resistance to penetration, ensuring liquids and microorganisms do not leak through tiny holes or imperfections. This means the gloves provide an effective barrier, protecting your hands from direct contact with hazardous chemicals and microbes.

  Test results

  Penetration Resistance Tested

  This product has passed a leak test to ensure it is a waterproof and effective barrier against liquids, bacteria, and fungi. This protects your hands from contact with harmful microorganisms in various work environments.

• 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.

  Reach out to ask about the standard test results

• 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.

• 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.

• 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.