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MaskSafe Ltd was founded in March 2020 during the height of the COVID-19 pandemic. We identified the need for a UK-based and UK-certified respiratory mask manufacturer as sub-standard and counterfeit respiratory protection has found its way into the supply chain, putting our carers at risk.

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MaskSafe’s mission is to manufacture quality CE certified respirators in full compliance with the EN149 Standard PPE-R/02.075 v2 to protect our healthcare workers against SARS-CoV-2. By purchasing superior raw materials & ultrasonic welding machinery, investing in thorough independent laboratory testing, and assembling our product under stringent ISO 9001 conditions, we can guarantee a product which will safeguard the user.
With a headquarters in Lancashire, we employ 30 staff and operate under stringent social distancing measures, utilising personal protective equipment and adhere to robust risk assessments in order to bring our product to market at a time when it is needed the most. Masksafe are well placed to support the UK’s & Europe’s frontline COVID-19 response and provide your supply chain with full UK resilience and certified / quality product.

The SARS-CoV-2 Range

  • Valved and Non-Valved Options available
  • Traditional ‘Duckbill’ design with additional space gives improved respiratory relief.
  • Improved audibility when communicating with patients

The N95/99 Range

  • Valved and Non-Valved Options available
  • Fold Flat N95/99 respirator.
  • Tested to N95/99 NIOSH/FDA Standard’s for export to USA

Prior to COVID-19 the full EN 149:2001 + A1:2009 legislation was in use to provide industry with respiratory protection to FFP3 and FFP2 standards. This meant that dust and particle would be filtered to a level of 99% for FFP3 and 94% for FFP2. Following the onset of the COVID-19 Pandemic the World Health Organisation issued guidance for FFP3 or FFP2 half face respirators to be used in aerosol generated environments where COVID-19 was present.

Unfortunately, there were not enough legitimate certified FFP3 and FFP2 masks on the market to supply front-line key workers and supply chain issues commenced. Organisations started to procure respiratory protection which had poor face fitting properties from ear loop securing as opposed to head harness securing. In June 2020, the UK HSE released a bulletin identifying Chinese KN95 masks as sub standard and non-compliant with European conformity. It was advised that KN95 Chinese standard masks should not be used in the UK for protection against COVID-19 (SARS-CoV-2).

Use of Masks Designated KN95

To enable suitable and sufficient respiratory protection to meet supply the European Commission provided emergency legislation which is newly documented in PPE-R/02.075 Version 2. Masks certified under this legislation will be evaluated to provide protection for the COVID 19 / SARS-CoV-2 virus only.

The assessment creates efficiencies in testing, by considering the EN 149 standard, omitting COVID-19 (SARS-CoV-2) nonspecific parts, and prioritising virus protection thus bringing the correct product to market in order to safe guard our health care and frontline workers.

Masksafe Ltd currently manufacture the full range to PPE-R/02.075 version 2.

The full PPE-R/02.075 Version 2 European Legislation can be viewed below via the link.

PPE-R/02.075 Version 2 European Legislation

  • QMS Registered 2015
  • QMS Registered 2015

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+44 (0)1942 936374
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Address

Unit 38, Leigh Commerce Park, Meadowcroft Way,
Leigh WN7 3XZ
England

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