Hygostar Type II 3-Ply PP Face Masks, Blue

Standards and labels

• EN 14683:2019

  EN 14683 is a European standard for face masks. It includes requirements for mask design, testing, and labeling. Test results include things like filtration efficiency and breathability. The standard also includes requirements for packaging and labeling. The 2019 version updates the previous 2014 version.

  Test results

  Bacterial Filtration Type II

  The Bacterial Filtration result for Type II in the EN 14683:2019 standard specifies a minimum bacterial filtration efficiency (BFE). The standard requires that Type II medical face masks must achieve at least a 98% BFE, which means that they are capable of filtering out at least 98% of the bacteria present in the testing aerosol. This is crucial for ensuring a high level of protection against the transmission of bacteria through respiratory droplets.

• 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.

• 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.