Summary of Contents for EARNTZ EZKZP2
- Page 1 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...
- Page 2 EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 2 of 28 Documents Revision History Rev. Date Revision History Signature 2020-03-28 New document Page 2 of 28...
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Page 3: Table Of Contents
EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 3 of 28 Table of Contents TABLE OF CONTENTS ....................3 CHAPTER 1 DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSIRIES ...................... 5 1.1 Device description and specification .............. - Page 4 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 4 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 ..................
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Page 5: And Accessiries
EARNTZ® uses a variety of new technologies and features to help you meet your respiratory protection and comfort needs. Page 5 of 28... -
Page 6: Intended Use
Page: Page 6 of 28 1.1.3 Intended use EARNTZ® Protective Face Mask helps provide respiratory protection against certain airborne particles. The folded respirator expands for a spacious feel and the pleats help increase surface area for ease of breathing. 1.1.4 Intended users Daily users, sports enthusiast, not for medical use. -
Page 7: Contraindications
1.1.10 Rationale for the qualification of the product We, SHANGHAI EARNTZ NONWOVEN.,LTD, hereby claim that, as legal manufacturer, we have established and maintained a quality management system according to Regulation 2016/425 for manufacturing of personal protective equipment. -
Page 8: Explanation For Novel Features
SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 8 of 28 Rationale: The Non-woven face masks are a single use and non-invasive medical device. The devices are intended to be wore to protect both patient and others persons from transfer of microorganisms, body fluid and particulate material. -
Page 9: Description Of The Key Functional Elements
EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 9 of 28 1.1.15 Description of the key functional elements Product components: EZKZP2 （FFP2） • CE marked FFP2 protective mask • Chinese KN95 rating •... -
Page 10: Raw Materials And Packaging Materials
EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 10 of 28 1.1.16 Raw materials and packaging materials Parts name Material Specification Material Face masks Polypropylene 25g/m white SSS Inner layer nonwoven... -
Page 11: Previous And Similar Generation Of The Device
EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 11 of 28 Differential pressure < 40 < 40 (Pa/cm 2 ) Splash resistance Not required Not required pressure (kPa) Microbial cleanliness ≤ 30 ≤... -
Page 12: Chapter 2 Information To Be Supplied By The Manufacturer
EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 12 of 28 Chapter 2 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER Annex I of Regulation (EU) 2016/425 EN 149：2001+A1:2009 The draft labels are given in the attachments: ... -
Page 13: Chapter 3 Design And Manufacturing Information
EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 13 of 28 Chapter 3 DESIGN AND MANUFACTURING INFORMATION 3.1 Design Information 3.1.1 Design and Development flow chart Page 15 of 28... -
Page 14: Design And Development Inputs
EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 14 of 28 3.1.2 Design and Development inputs Information for users When breathing, speaking, coughing, sneezing etc., one releases smaller or larger amounts of droplets of secretions from the mucous membranes in the mouth and nose. -
Page 15: Design And Development Outputs
V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 15 of 28 such factors as infection risk and mask fit should be carefully considered when choosing a mask. Conform to EN 149 standards... - Page 16 EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 16 of 28 Page 17 of 28...
- Page 17 EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Page: Technical File of Earntz Protective Face Mask Page 17 of 28 Page 17 of 28...
- Page 18 EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 18 of 28 Drawings of YMJ3 3.1.3.2 Purchase list Page 18 of 28...
- Page 19 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...
- Page 20 Instructions for outer packing Process/inspection form Document Name Document No. EZKZP2 Face mask Inspection procedures EZKZP3 Finished product inspection procedure 3.1.4.7 Labels on the package See Folder 2 # EZKZP2/P3. label for Medical Face Masks Page 20 of 28...
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Page 21: Manufacturing Information
EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 21 of 28 3.2 Manufacturing information 3.2.1 Production Process Flow Chart 3.2.2 Special processing validation Validation of the elastic bands welding and package heat sealing process has been conducted and the approved parameters are monitored during routine production. -
Page 22: Chapter 4 General Safety And Performance Requirements
EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 22 of 28 Chapter 4 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS 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). -
Page 23: Chapter 5 Benefit-Risk Analysis And Risk Management
EZKZ01 V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 23 of 28 Chapter 5 BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT Page 23 of 28... -
Page 24: Chapter 6 Product Verification And Validation
V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 24 of 28 Chapter 6 PRODUCT VERIFICATION AND VALIDATION The performances and characteristics of the device have been determined based on the intended purposes of the device, essential safety and performance requirements and the identified risks that might happen during the transport, storage and usage. -
Page 25: Usability Evaluation Report
V2.0 SHANGHAI EARNTZ NONWOVEN.,LTD Revision: Effective: 2020-03-28 Technical File of Earntz Protective Face Mask Page: Page 25 of 28 Nose piece The mask should be equipped with a nose piece, which is made of flexible materials and should be no less than 8.0cm in length.
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