Type IIR surgical mask

polypropylenelatex-freefiberglass-free

Our masks have achieved an average BFE of 99.99% in accredited tests thanks to our precise selection of materials and strict technological discipline. Non Woven disposable 3-layer medical mask with elastic bands, Class 1, Type IIR, (non-measuring, non-sterile) Color variants: - black Main components of the Product: - Non-woven fabric, 100% polypropylene: • - Spunbond 25 g / m2 - contact layer with face • - Meltblown 25 g / m2- filter layer • - Spunbond 25 g / m2 - top layer blue • - Elastic ear loops/bands (3mm round diameter) • - Shapeable carrying clip - fastening element of the medical mask on the root of the nose Size: - - - - 175 x 95mm Product ID: - - - GTIN8 588008 467022 - Medical device registration code: - P2066A EUDAMED MD registration code: - DVC-SK-21-02-000005 Packing: - - - - smallest package unit - box with 50 masks, dimensions 186 x 96 x 102 mm , with description in English language as well as pictogram instructions for use Conformity assessment procedure: - Slovak Government Regulation 166/2020 European directive: - COUNCIL DIRECTIVE 93/42 / EEC of 14 June 1993 concerning medical devices Standards used: - - STN EN 14683: 2019 + AC: 2019, " Medical face masks - Requirements and test methods“ Appendix B, Appendix C and ISO 22609 - STN EN ISO 10993-5; Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) - STN EN ISO 10993-10; Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) Test report: - - - B 258947 - - - - - STN EN ISO 15223-1: 2016 Test report: - - - B 258947