TEST REPORT Report No. : CH:TX: DATE : 22/02/2021 * *

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SANTE FE LIFESCIENCES PRIVATE LIMITED PLOT NO.138, SECTOR -7, IMT MANESAR GURGAON-122052

IN

CONTACT PERSON : Ms. HARJEET KAUR

THE FOLLOWING SAMPLE(S) WAS/WERE SUBMITTED AND IDENTIFIED BY/ON BEHALF OF THE CUSTOMER AS : SAMPLE DESCRIPTION MASK

N 95 RESPIRATOR/FFP2 NR

COLOUR WHITE

ORDER NUMBER SF/20-21/0033

STYLE NO. BREATHE EZ

ARTICLE NO. EZ 200

END USE IT IS INTENDED FOR PERSONAL PROTECTION,TO HELP REDUCE WEARER EXPOSURE TO AIRBORNE PARTICULATES, PROTECT AGAINST THE TRANSFER OF LIQUID AND SOLID AEROSOLS AND PARTICULATE MATERIAL

FIBRE CONTENT SPUN BONDED NON -WOVEN FABRIC, MELT- BLOWN FILTER, SPANDEX, ALUMINIUM

BUYER’S NAME SANTE FE LIFESCIENCES PRIVATE LIMITED

BUYING HOUSE PLOT NO.138, SECTOR -7, IMT MANESAR, GURGAON, HARYANA-122052 COUNTRY OF DESTINATION INDIA

COUNTRY OF ORIGIN INDIA PHOTO APPENDIX.

SAMPLE RECD ON 03/02/2021 TESTING PERIOD : 08/02/2021 - 22/02/2021

Summary of Test Results

Test Method Test Name Status / Performance Level

EN 149:2001+A1.2009

Respiratory protective devices – Filtering half maks to protect against particles

Packaging - Clause 7.4 Pass

Material - Clause 7.5 Pass

Cleaning and disinfecting - Clause 7.6 Not Applicable

Practical performance - Clause 7.7 Pass

Finish of parts - Clause 7.8 Pass

Total inward leakage - Clause 7.9.1 Pass

Penetration of filter material: Sodium chloride - Clause 7.9.2 Pass Penetration of filter material: Paraffin oil - Clause 7.9.2 Pass

Compatibility with skin - Clause 7.10 Pass

Flammability - Clause 7.11 Pass

Carbon dioxide content of the inhalation air - Clause 7.12 Pass

Head harness - Clause 7.13 Pass

Field of vision - Clause 7.14 Pass

Exhalation valve(s) - Clause 7.15 Not Applicable

Breathing resistance - Clause 7.16 Pass

Clogging - Clause 7.17 Not Applicable

Demountable parts - Clause 7.18 Not Applicable

Per pro SGS India Private Ltd.

R. GANESAN

SECTION INCHARGE

Email your Test Report Related Enquiries a t [email protected]

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R E S U L T S

BS EN 149:2001 + A1:2009 Respiratory protective devices — Filtering half masks to protect against particles

Clause 7.4 Packaging

The polyethane packaging cover has been provided to protect the particle filter half mask from mechanical damage or any contamination before use.

Clause 7.5 Material

After conditioning as per BS EN 149:2001+A1:2009 clause 8.3.1 & 8.3.2 the particle filter half mask doesn’t collapse Clause 7.6 Cleaning and disinfecting

Not applicable, not reusable Clause 7.7 Practical performance

No adverse comments were made by the test subject relating to any of the criteria assessed.

Clause 7.8 Finish of parts

The filtering half face mask and their parts doesn’t contain any sharp edges of burrs.

Clause 7.9 Leakage

Clause 7.9.1 Total inward leakage (%)

Subject Specimen Condition Walk Head

side/side

Head

up/down Talk Walk Mean

1 1 As Received 2.07 2.26 2.31 2.36 2.44 2.29

2 2 As Received 2.14 2.34 2.41 2.52 2.56 2.39

3 3 As Received 2.10 2.16 2.27 2.31 2.39 2.25

4 4 As Received 2.17 2.24 2.35 2.39 2.41 2.31

5 5 As Received 2.39 2.47 2.51 2.58 2.62 2.51

6 6 After temperature conditioning 2.67 2.76 2.84 2.91 2.98 2.83

7 7 After temperature conditioning 2.81 2.96 3.07 3.17 3.21 3.04

8 8 After temperature conditioning 2.91 3.09 3.19 3.27 3.34 3.16

9 9 After temperature conditioning 3.16 3.27 3.39 3.42 3.56 3.36

10 10 After temperature conditioning 3.21 3.34 3.46 3.51 3.62 3.43

Maximum permitted (FFP1) 25 22

Maximum permitted (FFP2) 11 8

Maximum permitted (FFP3) 5 2

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R E S U L T S

Subject facial dimensions:

Subject Face Length (mm)

Face Width (mm)

Face Depth (mm)

Mouth Width (mm)

1 110 160 121 50

2 120 162 128 65

3 110 160 120 55

4 115 150 105 70

5 110 161 120 54

6 117 167 117 55

7 114 164 115 67

8 110 162 120 65

9 117 167 118 72

10 114 164 124 68

Clause 7.9.2 Penetration of Filter Material Test Aerosol: Sodium Chloride 95 l/min

Sample Condition

Penetration %

Result After 3 minutes

1

As Received

0.56

Pass FFP2

2 0.72

3 0.78

1

After Simulated Wear

1.38

2 1.59

3 1.68

1 After mechanical strength + temperature conditioning

2.13

2 2.47

3 2.01

Max Permitted FFP1 20

Max Permitted FFP2 6

Max Permitted FFP3 1

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R E S U L T S

Clause 7.9.2 Penetration of Filter Material Test Aerosol: Paraffin Oil 95 l/min

Sample Condition

Penetration %

Result After 3 minutes

1

As Received

3.96

Pass FFP2

2 4.12

3 4.07

1

After Simulated Wear

4.81

2 5.29

3 4.93

1 After mechanical strength + temperature conditioning

5.88

2 5.37

3 5.80

Max Permitted FFP1 20

Max Permitted FFP2 6

Max Permitted FFP3 1

Clause 7.10 Compatibility with skin

Test subject doesn’t experience any skin irritation or any other adverse effect.

Clause 7.11 Flammability

Specimens (As received and After temperature conditioning) were tested, None of the specimens gets ignited.

Clause 7.12 Carbon dioxide content of the inhalation air

Specimen CO2 (%)

1 0.47

2 0.49

3 0.49

Maximum permitted 1.0

Clause 7.13 Head harness

Head harness present in the mask and test subject satisfied with accessability of the head harness.

Clause 7.14 Field of vision

The field of vision is acceptable by the test subject.

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R E S U L T S

Clause 7.15 Exahalation valve(s) Not applicable, no exahalation valve.

Clause 7.16 Breathing Resistance

Clause 7.17 Clogging

Manufacturer not claimed for clogging test, also it is optional test for single use mask.

Clause 7.18 Demountable parts

No demountable parts present in the mask.

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Specimen Condition

Inhalation resistance

(mbar) Exhalation resistance (mbar)

At 30 l/min At 95 l/min At 160 l/min

Facing directly ahead

Facing directly

ahead

Facing directly

ahead

Facing vertically

upwards

Facing vertically downwards

Lying on the left side

Lying on the right

side 1

As Received

0.65 2.32 2.80 2.84 2.81 2.81 2.82

2 0.60 2.30 2.87 2.88 2.86 2.90 2.87

3 0.62 2.30 2.87 2.81 2.80 2.84 2.85

1

After temperature conditioning

0.48 2.27 2.80 2.81 2.84 2.82 2.80

2 0.47 2.23 2.77 2.79 2.76 2.76 2.80

3 0.49 2.27 2.84 2.80 2.79 2.82 2.81

1

After Simulated wearing

0.56 2.21 2.86 2.88 2.90 2.85 2.87

2 0.57 2.19 2.80 2.81 2.86 2.85 2.88

3 0.54 2.20 2.90 2.91 2.88 2.86 2.90

Maximum permitted (FFP1) 0.6 2.1 3.0

Maximum permitted (FFP2) 0.7 2.4 3.0

Maximum permitted (FFP3) 1.0 3.0 3.0