The FFP3 mask is a Class I medical device that provides filtration efficiency of ≥ 99%. Its filtration efficiency has been confirmed by tests using particles ranging in size from 60 to 160 nanometers, corresponding to the size of the coronavirus. The mask is designed to provide a high level of respiratory protection during daily work.

The product features a chin seal system and ear loops with a sealing clip, which ensure a secure fit to the face. Each mask is individually packaged, and the bulk package contains 15 pieces. The product is intended for use for 8 hours and has been entered into the register of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

The FFP3 mask combines the high level of filtration characteristic of filtering half-masks with the comfortable, flat shape of a medical mask. It is valve-free, non-allergenic, and does not irritate the skin. Made of high-quality materials, it ensures microbiological safety and comfort during use.

This is a medical device. Use it in accordance with the instructions for use or the label.

Features

• Filtration ≥ 99% verified by tests using 60–160-nanometer particles corresponding to the size of the coronavirus
• very low breathing resistance
• high wearing comfort
• flat mask, valve-free
• with chin seal system
• ear loops with sealing clips
• prevents glasses from fogging
• designed for 8 hours of use
• hypoallergenic and non-irritating
• microbiologically clean
• bulk packaging 15 pieces
• packaged individually
• certificate of conformity with standard EN 149
• complies with standard EN 14683 for Types I, II, and IIR
• Meets the requirements of RPEiR 2017/745

Package contents

• 15 individually packaged FFP3 masks

Classification and Standards

• Class I medical device
• Compliance with standard EN 149:2001+A1:2009
• Meets the EN 14683 Type I, II, IIR standard
• Compliance with Directive 93/42/EEC

Instructions

Read the mask user manual → Mask User Manual

Application

• Medical personnel: The mask is ideal for the daily work of doctors, nurses, paramedics, laboratory technicians, and other healthcare facility staff.
• Dental offices: It can be used by dentists, dental hygienists, and assistants during procedures requiring a high level of respiratory protection.
• Hospitals and clinics: This product is intended for use in hospitals, clinics, doctors’ offices, diagnostic centers, and other medical facilities.
• Laboratories and diagnostic facilities: Suitable for people working in laboratories, specimen collection sites, and locations where maintaining a high level of hygiene and personal protection is essential.
• Work requiring high protection: The mask can be used by people working in environments that require the use of respiratory protection for extended periods.

Product and Responsible Party Identification Information

EAN Code: 5903754485336