Respiratory protective equipment and surgical mask

Face masks by Teho Filter Oy

Respiratory protective equipment and surgical mask

Face masks from Finland. Get acquainted with personal protective equipment and surgical masks manufactured by Teho Filter Oy. There are separate and specific production area in the production to ensure cleanliness. The materials are of high quality and carefully selected. All our products have passed strict tests and we follow the given directives and regulations throughout the production process. Covid-19 masks are only for professional use. The filtering half mask FFP2 NR fulfills the EN 149:2001 + A1:2009 and PPE regulation 2016/425 requirements. Our masks have CE marking and the four-digit identification number of the relevant notified body controlling their quality. Our surgical masks Type IIR are classified as medical devices and they have a CE marking.

Product information (in Finnish):

• TFM06_2S (IIR)
• TFM14(IIR)
• TFM07 (Covid-19)
• TFM12 (Covid-19)
• TFM33 (FFP2 NR)
• TFM32 (FFP2 NR)
• TFM31 (FFP2 NR)
• TFM31V (FFP2 NR)

Instructions for use (in English):

• TFM14
• TFM07
• TFM12
• TFM33  
• TFM32  
• TFM31  
• TFM31V  

Respiratory protective equipment (RPE) and civil masks

There are three main types of masks covering the nose and mouth:

• Civil masks include reusable cloth masks and disposable masks made of different materials. The purpose of civil masks is to reduce the spreading of droplets. Civil masks are common consumer goods. They cannot have a CE marking.
• Surgical masks are products intended to protect others, such as patients, and not their users. They are classified as medical devices. Surgical masks classified as medical devices must have a CE marking.
• Respiratory protective equipment is personal protective equipment. Its purpose is to protect the user of the product. Among others, respiratory protective equipment must have a CE marking and the four-digit identification number of the relevant notified body controlling their quality.

Masks have different purposes of use and are covered by different legislation.

Source: Tukes

Read more about face masks

• Requirements for respiratory protective equipment. The page opens in a new tab.
• Technical requirements of FFP standard respirators and surgical masks. The page opens in a new tab.

EU Declaration of Conformity

• Declaration of Conformity TFM06_2S
• Declaration of Conformity TFM14
• Declaration of Conformity TFM07
• Declaration of Conformity TFM12
• Declaration of Conformity TFM33
• Declaration of Conformity TFM32
• Declaration of Conformity TFM31
• Declaration of Conformity TFM31V

Management System Certificate

• The Quality Management System standard: ISO 9001
• The Environmental Management System standard: ISO 14001
• The Quality Management System standard: ISO 13485

Contact details