Genuine Face Masks – What to Look For

There are a number of ways to check if your facial protection is genuine – whether this is a surgical face mask or an FFP respirator. It can be a little confusing however when there are so many options available, with varying technical specifications depending on the supplier or product you choose. The guide below provides a simple checklist on what to look for by product, when selecting genuine face masks for yourself or your organisation. Surgical masks (non-sterile) – What to look for: • Is the mask type (Type I, Type II or Type IIR) marked on the packaging? • Is the name & address of manufacturer visible? • Can the name and address of the “EC Authorised Representative” be identified? • Are there instructions for use? • Is there an expiry date? • Are there handling and storage instructions? • Is there a CE mark? The CE mark ensures the product is suitable in Europe and the UK. • Is there a claim of compliance with EN 14683:2019 +AC:2009? • If the mark is suitable for single-use only, is the packaging marked as such? • If it’s re-usable, are there instructions for cleaning provided? • Can the manufacturer provide an EU Declaration of Conformity? • Does the Declaration of Conformity quote the relevant regulation? (93/42 or 2017/745) • Does the Declaration of Conformity identify the product(s) to which it relates? • Is the Declaration of Conformity signed and dated? • Can the manufacturer provide a test report to EN 14683:2019 +AC:2009?   Surgical masks (sterile) – Additional features to look for: • Does the packaging provide sterile marking, including sterilisation method? • Is the CE mark followed by a 4-digit number to guarantee who oversaw the testing? • Can the manufacturer provide a Notified Body certificate for the sterilisation process? • Is the Notified Body notified for Medical Devices on the EU Commission NANDO database? • Does Notified Body have a certificate checker site and does the certificate number match? • Is the certificate in date? • Does the Declaration of Conformity refer to the Notified Body for the sterilisation process?   FFP Respirators – What to look for: • Is the respirator type (FFP1, FFP2 or FFP3) marked clearly on the packaging? • Is the name and address of manufacturer visible? • Is there an EU Manufacturer’s Representative or Importer’s address available? • Are there instructions for use provided? • Are the application and any warnings & limitations clear? • Is there an expiry date? • Are there handling and storage guidelines outlined? • Does the EU Notified Body’s address appear? • Is there a CE mark (followed by a 4-digit number) on the packaging, and on each mask? • Is the Notified Body notified for PPE on the EU Commission NANDO database? • Can the manufacturer provide an EU Type Examination Certificate from the EU Notified Body? • Does the Notified Body have a certificate checker site and does the certificate number match? • Is the certificate in date? • Does the Declaration of Conformity refer to the Notified Body? • Is there a claim of compliance with EN 149: 2001 + A1: 2009 on the packaging and on each mask? • If the mask is recommended for single-use only, is the packaging marked as such? • If it’s re-usable, are the instructions for cleaning on the packaging/mask? • Can the manufacturer provide an EU Declaration of Conformity? • Does the Declaration of Conformity quote the relevant regulation? (2016/425)? • Does the Declaration of Conformity identify the product(s) to which it relates? • Is the Declaration of Conformity signed and dated? • Can the manufacturer provide a test report to EN 149: 2001 + A1: 2009?   At Allied PPE we can guarantee that we will tick all the above boxes when you check that you are receiving genuine face masks with the correct certification and testing. We hold a huge stock of Type IIR surgical face masks and FFP2 respirators in the UK that are available at great prices and ready for immediate delivery. Whether you’re looking for a single box or a bulk order, we can help! To talk to us about your requirements call the number at the top of the page or enquire online.

For more information on Genuine Face Masks – What to Look For talk to Allied PPE