Unigloves Unicare Powdered blue vinyl 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 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 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.

  Reach out to ask about the standard test results

• 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 1

  PPE stands for "personal protective equipment." PPE Category 1 refers to equipment that is simple and easy to use, and has a lower level of risk. Examples of PPE Category 1 include gloves, goggles, and simple respirators. In Europe, PPE Category 1 must meet certain safety standards set by the European Union. This 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.