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MEDICAL FACE MASK

EN 14683

Medical face masks: Features

MEDICAL FACE MASK

• Class I Non-Sterile Medical Device
• EN 14683
• With earloops / Tie-on
• Splash resistant (type IIR)
• CE marked
• QMS in compliance to ISO 13485, as required by HSE and MHRA in the UK *

For more product and regulatory details, please contact us.

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*According to Technical Specifications for Personal Protective Equipment (PPE) written by the Health and Safety Executive (HSE) and the Medicines and Healthcare products Regulatory Agency (MHRA), and issued by UK Government, Disposable half mask respirators shall meet the following requirements [1]:

• Manufacturer must have quality management system in place such as evidence of compliance to ISO 9001 or BS EN 13485. 

• BS EN 14683:2019 Medical face masks. Requirements and test methods.

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Type I medical face masks should only be used for patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations. Type I masks are not intended for use by healthcare professionals in an operating room or in other medical settings with similar requirements. (according to EN 14683:2019)

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[1] Technical Specifications for Personal Protective Equipment (PPE). Essential Technical Specifications (Face Masks, Gloves, Gowns, Coveralls, Respirators, Eye Protection) - PDF. UK Gov. (v3 - 05/05/20). Available from: https://www.gov.uk/government/publications/technical-specifications-for-personal-protective-equipment-ppe

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Medical face masks: Text
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