EARNTZ EZKZP2 Guide

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
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Documents Revision History
Rev. Date Revision History Signature
A/0 2020-03-28 New document

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Table of Contents
TABLE OF CONTENTS................................................................................................. 3
CHAPTER 1 DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS
AND ACCESSIRIES ...................................................................................................... 5
1.1 Device description and specification ....................................................................5
1.1.1 Name and address of the manufacturer ...........................................................................5
1.1.2 Device name and general description of the device .....................................................5
1.1.3 Intended use...............................................................................................................................6
1.1.4 Intended users ...........................................................................................................................6
1.1.5 Basic UDI-DI ...............................................................................................................................6
1.1.6 The disease status to be diagnosed/targeted/monitored ...........................................6
1.1.7 Contraindications......................................................................................................................7
1.1.8 Waring and Cautions ...............................................................................................................7
1.1.9 Description of the principle ...................................................................................................7
1.1.10 Rationale for the qualification of the product ...............................................................7
1.1.11 Classification rule(s) ...............................................................................................................7
1.1.12 Explanation for novel features............................................................................................8
1.1.13 Description 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 Product Specifications........................................................................................................ 10
1.2 Previous and similar generation ofthe device.................................................... 11
1.3 EC Authorized Representative...........................................................................12
1.4 CND code........................................................................................................... 13
1.5 Declaration of conformity.................................................................................... 13
CHAPTER 2 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER........... 14
CHAPTER 3 DESIGN AND MANUFACTURING INFORMATION............................... 15
3.1 Design Information.............................................................................................15
3.1.1 Design and Development flow chart ............................................................................... 15
3.1.2 Design and Development inputs ...................................................................................... 16
3.1.3 Design and Development Outputs................................................................................... 17
3.2 Manufacturing information..................................................................................21
3.2.1 Production Process Flow Chart.......................................................................................... 21
3.2.2 Special processing validation ............................................................................................. 21
3.2.3 Inspects and controls the environment .......................................................................... 21
CHAPTER 4 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS ............ 22
4.1 General safety and performance requirements.................................................. 22
4.2 Applicable standards lists................................................................................... 22
CHAPTER 5 BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT....................... 23

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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 Packaging aging and Transportation evaluation reports .................................... 25
CHAPTER 7 CLINICAL EVALUATION....................................................................... 27
CHAPTER 8 POST-MARKET SURVEILLANCE......................................................... 28

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Chapter 1 DEVICE DESCRIPTION AND SPECIFICATION,
INCLUDING VARIANTS AND ACCESSIRIES
1.1 Device description and specification
1.1.1 Name and address of the manufacturer
Name of Manufacturer:
SHANGHAI EARNTZ NONWOVEN.,LTD
Address:
No.88 JIAN GONG ROAD,JIN SHAN DISTRICT, SHANGHAI, CHINA
Contact：
Contact Person: JUN JIE HU
Email: [email protected]om
Name of Factory/producer:
SHANGHAI EARNTZ NONWOVEN.,LTD
Address:
No.88 JIAN GONG ROAD,JIN SHAN 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 FFP3Protective Face Masks are constructed with a four-layer filtration system of
nonwoven soft and breathable fiber for effective protection. The masks feature extra soft and
comfortable elastic ear loops that will not apply pressure to the ears during use and have an
adjustable nose bridge strip. The masks come in a single size that fits most faces. The disposable
masks should be replaced daily for best hygiene and are ideal for one-time use in a non-medical
setting.
EARNTZ® uses a variety of new technologies and features to help you meet your respiratory
protection and comfort needs.

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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.
1.1.5 Basic UDI-DI
The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned
at the level of the device unit of use. It is 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
of device and that is also used as the ‘ access key’ to information stored in a UDI
database.
UDI-PI: The UDI-PI is a numeric or alphanumeric code that identifies the unit of
device production. The different types of UDI-PIs include serial number, lot
number, software identification and manufacturing or expiry date or both types of
date.
A UDI shall be assigned to the device itself or its packaging. The UDI shall contain
two parts: a UDI-DI and a UDI-PI. The UDI-DI shall be unique at each level of
device packaging.
UDI-DI: it is not applicable
1.1.6 The disease status to be diagnosed/targeted/monitored
None

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1.1.7 Contraindications
None
1.1.8 Waring and Cautions
−If there is redness, swelling and itching after usage, please stop using it and consult
your physician.
−Only for single use.
−Stay away from fire.
−Correctly distinguish the front and back prior to use.
−The device should be stored in a dry room with excellent ventilation and without
caustic gases.
−Can not be used on surgical operation condition.
−Not suitable for children under 3 years old.
1.1.9 Description of the principle
Non-woven fabrics have the characteristics of water repellency, air permeability,
flexibility and light weight. Therefore, choosing suitable 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 as 1-5μm.
These fibers with unique capillary structure can increase the number and surface area
of fibers per unit area, effectively filter bacteria and dust, and prevent the spread of
infectious pathogens. In addition, the design of nose clip and the design of mask stack
can make the mask fit the shape of face, thus reducing the probability of infectious
pathogens entering from the side.
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.
1.1.11 Classification rule(s)
Device Name: Protective Face Mask
According to Regulation (EU) 2016/425 :

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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.
1.1.12 Explanation for novel features
None
1.1.13 Description of the accessories
None
1.1.14 Description of the Variant configurations/ variants
Model
Classifi
cation
Character
istic
Size Color Layer Picture
EZKZP
2 FFP2 16.5cm(L)x 13.8cm(W)
x0.1cm(H)
white 3
EKKZP
3 FFP3 16.5cm(L)x
13.8cm(W)
x0.1cm(H)
white 4

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1.1.15 Description of the key functional 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 marked FFP3 protective mask (BSI)
• China KN99 rating (on going)
• NOISH N99 rating (on going)
• Optional nose bridge strip
• Four layers of filtration
• V-shaped pleats
• Flat-fold style
• Elastic ear loop

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1.1.16 Raw materials and packaging materials
NO. Parts name Material Specification Material
1. Face masks
Inner layer Polypropylene nonwoven 25g/m
2
white SSS
spunbond
nonwoven
2.
Face masks
middle layer
(FFP2)
Polypropylene melt-
blown non-woven
fabric
25g/m2melt-blown non-
woven fabric
3.
Face 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 fabric
5. Ear loop Elastic
nonwoven Elastic Polypropylene
7.
Nose Bridge
Strip
Aluminum +
adhesive tape
8. Inner package PET+PE Independent
packaging with CE
mark
9. Outer box Double corrugated box 600-700g/m
2
double
corrugated
1.1.17 Product Specifications
Table 1. Basic dimensions (unit ： mm)
Model
Size
EZKZP2
16.5 x 13.8cm
EZKZP3
16.5 x 13.8cm
Table 2 Performance requirements
Type
Test
Type Ⅱ
EZKZP2
EZKZP3
Bacterial filtration
efficiency (BFE), (%)
≥95% ≥99%

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Differential pressure
(Pa/cm 2 )
< 40 < 40
Splash resistance
pressure (kPa)
Not required Not required
Microbial cleanliness
(cfu/g)
≤30 ≤30
1.2 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 international
markets:
1.3 EC Authorized Representative
Folder 01 # CE-01-0102: EU authorized representative agreement
1.4 CND code
CND code:
1.5 Declaration of conformity
Declaration of Conformity for Face Masks is attached in the attachment.
Folder 01# CE-01-0103_Declaration of Conformity

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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:
Folder 02 # EZKZP2/P3_Label

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Chapter 3 DESIGN AND MANUFACTURING INFORMATION
3.1 Design Information
3.1.1 Design and Development flow chart

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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.
Those droplets quickly evaporate and leave nuclei suspended in the air. The majority of
the nuclei are between 0.5 μm and 12 μm in diameter and especially the larger droplets
can contain micro-organisms from the source site. Nuclei can subsequently spread
through the air to a susceptible site such as an open operating wound or sterile
equipment.
The level of efficiency offered by a mask depends on a number of factors such as the
filtration efficiency, quality of the material and the fit of the mask on the wearer’s face.
Different designs are suited for different applications and the careful choice of mask is
therefore important in order to achieve the desired result.
The filtration capacity of mask materials can vary depending on the filter media. The fit
of masks varies considerably from those which are held in place by ear loops fastened
behind the wearer’s ears to those with tie bands around the head and a nose clamp
that can be shaped to the wearer’s nose. The effect of a very good or less good 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 groups of test subjects and observations. It is thus usual to characterise mask
performance using in vitro tests of the material from which the mask is made. It is,
however, important to consider the fit of the mask carefully when a mask for a certain
application is chosen. Users should request such information from their suppliers.
A further factor to be considered is the capacity of the mask to absorb moisture from
the exhaled air and thereby to maintain its performance over a longer period of time.
The more advanced designs easily maintain their performance throughout even very
long operations whereas the less advanced ones are intended only for short
procedures.
The contamination risk resulting from hand contact with a used mask means that it is
essential that the mask is taken off and disposed of when no longer worn over nose and
mouth. When there is a further need for protection then a new mask should be put on.
Touching a used face mask or putting on a new one should always be followed by a full
hand disinfection procedure and a used mask should always be disposed of when no
longer needed or between two procedures.
In summary, to use an appropriate mask is an effective means to protect the working
environment from droplet contamination from nose and throat during health care
procedures. Masks with very different performance are, however, available. Therefore

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such factors 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 pressure
(Pa/cm 2 )
< 40 < 40
Splash resistance
pressure (kPa)
Not required Not required
Microbial cleanliness
(cfu/g)
≤30 ≤30
3.1.3 Design and DevelopmentOutputs
3.1.3.1 Drawings

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Drawings of YMJ3
3.1.3.2 Purchase list

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3.1.3.3 Production description
The materials of medical face masks are purchased from abroad, and the production
process includes feeding, welding, packaging and warehousing. For the main raw
materials/purchased parts, we will select the enterprises with good quality and high
delivery efficiency from the suppliers for 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 an allowable tolerance of 5%
Appearance The appearance of the mask should be smooth,
without damage, stains, deformation and other
obvious defects.
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.
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.

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3.1.4.6 Documents on the Process operation
Technical File
No.
Document Name
Document No.
1
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 for outer packing
Process/inspection form
No.
Document Name
Document No.
1
EZKZP2 Face mask Inspection
procedures
2
EZKZP3 Finished product inspection
procedure
3.1.4.7 Labels on the package
See Folder 2 # EZKZP2/P3. label for Medical Face Masks