Suavel® Protec Black Surgical mask with elastic ear loops, Black, Type II

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 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 II

  This medical face mask filters at least 98% of bacteria. It is intended for use in medical settings to prevent the transmission of infectious agents from staff to patients and is also suitable for public use.