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SHANGHAI EARNTZ NONWOVEN.,LTD

Technical Documentation

Protective Face Masks

according to

Regulation 2016/425

Drafted by:

JUNJIE HU

Reviewed by:

JUNJIE HU

File number:

EZKZ01

Revision

V2.0

Effective

2020.03.28

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Содержание EZKZP2

Страница 1: ...ANGHAI EARNTZ NONWOVEN LTD Technical Documentation Protective Face Masks according to Regulation 2016 425 Drafted by JUNJIE HU Reviewed by JUNJIE HU File number EZKZ01 Revision V2 0 Effective 2020 03...

Страница 2: ...Page EZKZ01 V2 0 2020 03 28 Page 2 of 28 SHANGHAI EARNTZ NONWOVEN LTD Technical File of Earntz Protective Face Mask Page 2 of 28 Documents Revision History Rev Date Revision History Signature A 0 202...

Страница 3: ...cription of the accessories 8 1 1 14 Description of the Variant configurations variants 8 1 1 15 Description of the key functional elements 9 1 1 16 Raw materials and packaging materials 10 1 1 17 Pro...

Страница 4: ...ective Face Mask Page 3 of 28 CHAPTER 6 PRODUCT VERIFICATION AND VALIDATION 24 6 1 Biocompatibility test report 24 6 2 Product performance test report 24 6 3 Usability evaluation report 25 6 4 Packagi...

Страница 5: ...AN DISTRICT SHANGHAI CHINA 1 1 2 Device name and general description of the device Device Name Protective Face Mask Model EZKZP2 EZKZP3 General description of the device The disposable FFP3 Protective...

Страница 6: ...the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity UDI DI The UDI DI is a unique numeric or alphanumeric code specific to a model...

Страница 7: ...ble thickness of outer non woven fabrics can protect the wearer from potential contaminated liquid splashing In addition the fiber diameter of the intermediate melt blown filter layer can be as small...

Страница 8: ...es are intended to be wore to protect both patient and others persons from transfer of microorganisms body fluid and particulate material 1 1 12 Explanation for novel features None 1 1 13 Description...

Страница 9: ...ctional elements Product components EZKZP2 FFP2 CE marked FFP2 protective mask Chinese KN95 rating FDA certificate Optional nose clip V shaped pleats Flat fold style Elastic ear loop EZKEP3 FFP3 CE ma...

Страница 10: ...ce masks middle layer1 2 Polypropylene melt blown non woven fabric Two layers of 25g m2 melt blown non woven fabric 4 Face masks outer layer Polypropylene nonwoven 50g m2 blue white pink non woven fab...

Страница 11: ...2 Previous and similar generation of the device Overview of the previous generations of the device produced by the manufacturer None Overview of identified similar devices available on the Union or in...

Страница 12: ...GHAI EARNTZ NONWOVEN LTD Technical File of Earntz Protective Face Mask Page 14 of 28 Chapter 2 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER Annex I of Regulation EU 2016 425 EN 149 2001 A1 2009 The...

Страница 13: ...01 V2 0 2020 03 28 Page 13 of 28 SHANGHAI EARNTZ NONWOVEN LTD Technical File of Earntz Protective Face Mask Page 15 of 28 Chapter 3 DESIGN AND MANUFACTURING INFORMATION 3 1 Design Information 3 1 1 De...

Страница 14: ...ood fit can be tested in vivo whereas the filtration efficiency may be reproducibly tested in vitro The considerable variations in results when masks are tested in vivo results in the need for large g...

Страница 15: ...s as infection risk and mask fit should be carefully considered when choosing a mask Conform to EN 149 standards Type Test Type EZKZP2 EZKZP3 Bacterial filtration efficiency BFE 95 99 Differential pre...

Страница 16: ...No Revision Effective Page EZKZ01 V2 0 2020 03 28 Page 16 of 28 SHANGHAI EARNTZ NONWOVEN LTD Technical File of Earntz Protective Face Mask Page 17 of 28...

Страница 17: ...No Revision Effective Page EZKZ01 V2 0 2020 03 28 Page 17 of 28 SHANGHAI EARNTZ NONWOVEN LTD Technical File of Earntz Protective Face Mask Page 17 of 28...

Страница 18: ...No Revision Effective Page EZKZ01 V2 0 2020 03 28 Page 18 of 28 SHANGHAI EARNTZ NONWOVEN LTD Technical File of Earntz Protective Face Mask Page 18 of 28 Drawings of YMJ3 3 1 3 2 Purchase list...

Страница 19: ...r cooperation 3 1 3 4 Labels on the package See Folder 2 EZKZP2 P3 label for Protective Face Masks 3 1 4 5 Product specification Dimension The size of the mask should meet the design requirements with...

Страница 20: ...Medical Face Masks technical requirements Control procedure and Process SOP No Document Name Document No 1 Material preparation post operation procedure 2 Instructions for inner packing 3 Instructions...

Страница 21: ...monitored during routine production No Document Name Document No 1 Procedures for operation and maintenance of mask machine 2 Operation and maintenance of plastic film continuous sealing machine 3 2...

Страница 22: ...4 1 General safety and performance requirements The device has fulfilled all applicable Essential safety and performance requirements per Annex I of Regulation EU 2016 425 PPE Applicable standards li...

Страница 23: ...Revision Effective Page EZKZ01 V2 0 2020 03 28 Page 23 of 28 SHANGHAI EARNTZ NONWOVEN LTD Technical File of Earntz Protective Face Mask Page 23 of 28 Chapter 5 BENEFIT RISK ANALYSIS AND RISK MANAGEME...

Страница 24: ...authority concerning cytotoxicity irritation and sensitization it is concluded that the biocompatibility of the product is in line with essential safety and performance requirements from MDR Folder 6...

Страница 25: ...length Elastic bands The Elastic bands should be elastic and suitable the rupture strength of the mask belt and the connection between the mask belt and the mask body should be no less than 10N Differ...

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