About Us
Established in 2020, NorthWest Medical is a manufacturer of Type IIR Face Masks with Ties and Loops.
Through our knowledge and expertise we have developed an environment capable of producing to the very highest standard right here in Northern Ireland.
All production occurs in an ISO Class 8 Cleanroom
Quality Management System to ISO 13485
Environmental monitoring Programme in Place for Hygiene Validation as per EN14683
Products tested in accordance with EN 14683:2019 + AC 2019 by an approved EN 14683 testing facility.
Full compliance with EU Medical Device Regulation 2017:745 (EU:MDR)
Products tested for US Market in accordance with ASTM F2100-19.
Masks also tested for Biocompatibility as required under MDR Regs to the following standards:
ISO 10993-5 Cytotoxicity (Toxic to living cells)
ISO 10993 - 10 Testing for skin irritation and sensitisation.
Masks age tested to international standard ASTM1980
Masks tested for flammability to 16 CFR Part 1610
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