Kolmi Mass Balance Oxygen Mask FFP3, Type IIR, Indiviudally Packed, Size M, White

Standards and labels

• EN 149:2001+A1:2009

  Filtering half masks (respirators) with the EN 149:2001+A1:2009 rating are tested for their filtering efficiency against airborne particles, breathing resistance, and secure fit. This ensures the mask effectively protects your respiratory system and helps you choose the right level of filtration (FFP1, FFP2, FFP3) and reusability.

  Test results

  Reusability NR - Not Reusable

  This filtering facepiece protects against particles like dusts, mists, and aerosols. It is marked "NR" for "Non-Reusable," meaning it is intended for single-shift use only and should be discarded after one use.

  Dolomite Test D

  This mask passed an optional dolomite dust clogging test. This proves it provides more comfortable breathing and longer-lasting filtration performance, making it suitable for extended use in very dusty environments.

• EN 14683:2019

  Medical face masks with the EN 14683:2019 rating are tested for bacterial filtration efficiency, breathability, splash resistance, and microbial cleanliness. This means the mask has been assessed to help limit the spread of infective agents while allowing you to breathe comfortably.

  Test results

  Bacterial Filtration Type IIR

  This mask provides a high bacterial filtration efficiency of over 98% and is resistant to splashes of bodily fluids. It is designed to protect against spreading infectious droplets and for situations with a risk of fluid exposure.

• EN ISO 11737-1:2018/A1:2021

  Healthcare products and medical devices with the EN ISO 11737-1:2018/A1:2021 rating are tested for the amount of live microorganisms on them. This ensures these products are microbiologically safe, confirming effective sterilization and reducing infection risks for users.

  Reach out to ask about the standard test results

• 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.

• 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.

• 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.

• Dermatologically Tested

  Dermatologically Tested refers to products that have been tested and proven to be safe for use on the skin. The European Union has regulations for cosmetics products, which includes dermatological testing, to ensure that products are safe for use. To be labeled as dermatologically tested, the product must be tested by a qualified professional, such as a dermatologist, and must not cause any irritation or allergic reactions. The testing must be carried out on a representative sample of human volunteers and the results must be evaluated by a qualified professional before the product can be considered as dermatologically tested and can bear the label. The EU Cosmetics Regulation, lays out the specific requirements for safety assessments and labeling of cosmetics products.