Result Disposable 3 ply medical mask RV04X (pack of 50)
May 19, 2020
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Regatta Disposable 3 ply medical masks (pack of 10)

18.00 (Inc VAT)

SKU: n/a. Categories: , , , .


Class 1 Medical device: Disposable 3 ply Medical face mask with ear loop.

This has been manufactured under the guidance outlined in the medical devices directive 93/42/EEC (MDD)

This is not PPE and is not certified under the PPE Regulation (EU) 2016/42.

The item is a Type I mask which means it is suitable to reduce the risk of spread of infections.

In terms of performance the type I mask meets the below:

bacteria filtering effectiveness > 95%.

differential pressure < 40

splash resistance (not tested) Not applicable to type I

Microbial cleanliness < 30

The product is manufactured :

– following the requirements outlined in EN14683 – our manufacturer has provided evidence to show the product meets EN14683, and we are further testing the product with ITS as additional due diligence.

– under an approved quality management system which meets ISO 13485, this has been performed and issued by SGS.

The product is single use only & is non sterile.


Additional information