MicroFlex MK XTRA 93-862

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 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.

  Test results

  Radiation & Contamination Tested

  This product provides protection against radioactive contamination and ionizing radiation. It is liquid-proof to prevent penetration by contaminated substances and may contain lead or equivalent metals to shield against radiation, making it suitable for handling radioactive materials.

• EN ISO 21420:2020

  Protective gloves, mittens, and arm protectors with the EN ISO 21420:2020 rating are tested for general requirements like material safety, comfortable fit, and dexterity. This ensures the products are safe against your skin, provide a good fit, and allow for easy hand movement while you use them.

  Test results

  General Requirements Guide

  Ensures protective gloves meet general requirements for design, comfort, and safety. It guarantees the materials won't harm you, are sized correctly for better dexterity, and are constructed to be easily put on and taken off.

• EN ISO 9001:2015

  Products with the EN ISO 9001:2015 rating are tested for consistent quality management processes to meet customer and regulatory requirements. This means you can expect reliable products and services, as the company is committed to improving customer satisfaction.

  Test results

  Service Reliability Passed

  This product is backed by a quality management system that ensures you receive consistent and dependable service. It focuses on providing reliable support and a positive customer experience, from initial contact to post-delivery activities.

• EN ISO 374-5:2016

  Gloves with the EN ISO 374-5:2016 rating are tested for protection against microorganisms, including bacteria, fungi, and potentially viruses. This means the gloves act as a barrier, helping to prevent contact with and transmission of these harmful biological agents for improved hygiene and safety.

  Test results

  Micro-organisms Bacteria & Fungi

  This product provides a protective barrier against bacteria and fungi. It is tested to ensure it does not leak, making it useful for tasks where you need to avoid direct contact with these micro-organisms.

• EN ISO 374-1:2016

  Gloves with the EN ISO 374-1:2016 rating are tested for resistance against specific hazardous chemicals and microorganisms, including permeation, penetration, and degradation. This rating helps you choose gloves that provide the right level of protection for safely handling various dangerous substances.

  Test results

  Specified Requirements Type B

  This glove provides protection against chemical splashes, resisting permeation from at least three specific chemicals for over 30 minutes. It is ideal for tasks involving moderate contact with listed hazardous substances.

• 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.