TFM14 Surgical mouth-nose protector, 10pcs/PKT, black TYPE IIR

TFM14 Surgical Mouth-Nose Protector Type IIR

Product conformity and clinical assessment

The product meets the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council. The product is manufactured according to the quality management system described in ISO 13485:2016 + AC:2018. The risk class of the oral nose protector medical device shall be I (Regulation 1) in accordance with the rules set out in Annex VIII to the Regulation. The mouth-nose protector meets the requirements of the European standard EN 14683:2019 and has a test report for an accredited laboratory in accordance with the standard adopted. The product has been successfully tested in accordance with EN 14683:2019 + AC:2019 Class IIR and EN ISO 10993-5 and EN ISO 10993-10. EN ISO 10993-5 ensures that the product is not cytotoxy and EN ISO 10993-10 ensures that the product does not irritate or sensitive skin.  EU declaration of conformity TFM14 forsurgical mouth-nose protector.

Use and storage

The product is a mouth-nose protector. The product is disposable. The mouth-nose protector reduces the risk of the user's exposure to splashes and protects the environment from the spread of respiratory secretion. Please refer to the labels and instructions for use before use. Store mouth-nose protectors in a dry room between -5°C and +40°C, with relative humidity below 65%. Expiry date in housing (yyyy-mm-dd).

Makeup

• Interior material: PP Spunbond Nonwoven
• Filtering material: Polypropylene (PP)
• Outdoor material: Nonwoven made of polypropylene (PP) with blue/black colour and hydro-phobic treatment
• Nose support material: Plastic coated metal styling band
• Ear loops: Spandex+pet 70+150d latex free/none fluorescence

Product information

• Manufactured in Finland. Manufacturer Teho Filter Oy.
• Class IIR surgical mouth-nose protector.
• CE marked medical device.
• It's not cytoxyctic.
• Does not irritate or sensitive skin.
• The products are manufactured in a validated cleanroom.
• No chemicals have been used in the product.
• 10 and 50 pieces for sale in the case.
• Available in blue and black.

Product features

• Surgical mouth-nose protector
• Protection class IIR
• CE marked medical device
• Manufactured in Finland
• No chemicals have been used in the product
• Non-cytotoxyctic
• Does not irritate or sensitive skin
• Available in blue and black
• Sales packages 10 pcs and 50 pcs

Intended use of the product

• The product is a disposable mouth-nose protector.
• The mouth-nose protector reduces the risk of the user's exposure to splashes and protects the environment from the spread of respiratory secretion.