Kolmi Mass Balance Oxygen Mask FFP2, Type IIR, Size M, White

Standards and labels

Standards have not been specified

• 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.

• 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.

• 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.