masques medical type iirhunan mendale hometextile co., ltd 168 guyuan road,lugu industry...

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MASQUES MEDICAL TYPE IIR NORME EN14683 NORME EN 14683 : 2019+AC2019 / YY/T 0969-2013 et certifiés CE PRODUIT MASQUE CHIRUGICAL TYPEIIR MARQUE MENDALE USINE HUANA MENDALE HOMETEXTILE CO LTD NORME EN 14683 : 2019+AC2019 / YY/T 0969-2013 CERTIFICATION CE SGS CERTIFICAT CEN° GZHLVOC202004004 LABORATOIRE GTTC TEST REPORTN° 20R000098MT

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Page 1: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

MASQUES MEDICALTYPE IIR

NORME EN14683

NORME EN 14683 : 2019+AC2019 / YY/T 0969-2013 et certifiés CE

PRODUIT MASQUE CHIRUGICAL TYPEIIRMARQUE MENDALEUSINE HUANA MENDALE HOMETEXTILE COLTDNORME EN 14683 : 2019+AC2019 / YY/T0969-2013CERTIFICATIONCE SGSCERTIFICAT CEN° GZHLVOC202004004LABORATOIRE GTTCTEST REPORTN° 20R000098MT

Page 2: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

PHOTOS

Page 3: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

PHOTOS

Page 4: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

PHOTOS

Page 5: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

DESCRIPTIF

• Masques médical non tisse ́s

• 3 couches de protection

• Taille 17cm x 9,5cm

• Fixation par boucles e ́lastique ́es

• Barrette nasale souple

• Efficacite ́ de filtration bacte ́rienne >98 %

• Couleur blanc

Page 6: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

CONDITIONNEMENT

• DANS UNE BOITE- 50 PIECES

• DANS UN CARTON – 2000 PIECES

• DISPONIBLE EN STOCK

• LIVRAISON 48H OU RETRAIT A BOBIGNY

Page 7: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

Copyright of this verification is owned by SGS-CSTC Standards Technical Services Co., Ltd. (Shanghai) and may not be reproduced other than in full and with the prior approval of the General Manager. This verification is subjected to the governance of the General Conditions of Services, printed overleaf.

Member of SGS Group (Société Générale de Surveillance)

Note: You may contact us to validate this document by email address: [email protected] SHE-VOC-F001 / V1.1

Effective Date :2019-02-25

Reference: GZHLVOC2020040004 Page 1 of 1

VERIFICATION OF CONFORMITY Product˖̟̟̟ Disposable medical mask(non-sterile)

Tested by request of˖̟̟̟�������� Hunan Mendale Hometextile Co., Ltd. 168 Guyuan Road, Lugu Industry Base, Hi-tech Industrial Development Zone, Changsha City, China

Manufactured at˖̟̟̟��������Hunan Mendale Hometextile Co., Ltd.

168 Guyuan Road, Lugu Industry Base, Hi-tech Industrial Development Zone, Changsha City, China

Trade mark˖̟̟̟�������������������������������������������������������������������������������������������������������� /

Model/Type Ref˖̟̟̟��������1189960000

Ratings and principal characteristics: Size: 17cm×9.5cm.

Additional information: For model differences if any, please refer to test report.

Date of Expire: 2021-04-26

Samples for identified model as above listed have been tested and found to be in conformity with applicable requirements of following standards: EN 14683:2019+AC:2019 Type IIR

as shown in the test reports:

20R000098MT

This Verification of Conformity is the result of testing a sample of the product submitted, in accordance with the provisions of the relevant specific standard. It does not imply an assessment of the whole production. Conformity of the produced products with the specimen tested remains on the full responsibility of the manufacturer.

Guangzhou Branch 2020-04-27

Page 8: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

Copyright of this verification is owned by SGS-CSTC Standards Technical Services Co., Ltd. (Shanghai) and may not be reproduced other than in full and with the prior approval of the General Manager. This verification is subjected to the governance of the General Conditions of Services, printed overleaf.

Member of SGS Group (Société Générale de Surveillance)

Note: You may contact us to validate this document by email address: [email protected] SHE-VOC-F001 / V1.1

Effective Date :2019-02-25

Reference: GZHLVOC2020040004 Page 1 of 1

VERIFICATION OF CONFORMITY Product˖̟̟̟ Disposable medical mask(non-sterile)

Tested by request of˖̟̟̟�������� Hunan Mendale Hometextile Co., Ltd. 168 Guyuan Road, Lugu Industry Base, Hi-tech Industrial Development Zone, Changsha City, China

Manufactured at˖̟̟̟��������Hunan Mendale Hometextile Co., Ltd.

168 Guyuan Road, Lugu Industry Base, Hi-tech Industrial Development Zone, Changsha City, China

Trade mark˖̟̟̟�������������������������������������������������������������������������������������������������������� /

Model/Type Ref˖̟̟̟��������1189960000

Ratings and principal characteristics: Size: 17cm×9.5cm.

Additional information: For model differences if any, please refer to test report.

Date of Expire: 2021-04-26

Samples for identified model as above listed have been tested and found to be in conformity with applicable requirements of following standards: EN 14683:2019+AC:2019 Type IIR

as shown in the test reports:

20R000098MT

This Verification of Conformity is the result of testing a sample of the product submitted, in accordance with the provisions of the relevant specific standard. It does not imply an assessment of the whole production. Conformity of the produced products with the specimen tested remains on the full responsibility of the manufacturer.

Guangzhou Branch 2020-04-27

Page 9: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

Page 10: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

Applicant:Address:

HUNAN MENDALE HOMETEXTILE CO., LTD168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA

Bacterial filtration efficiency (BFE) MMicrobial cleanliness MDifferential pressure MSplash resistance pressure MMaterials and construction MDesign MGeneral M

Date Received/Date Test Started: 2020-03-21

Information confirmed by applicant:Disposable medical mask(non-sterile)Quantity: sixty piecesLot number: 20200310Model: 1189960000Size: 17cm×9.5cmClassification: Type RⅡ------------------------------

Conclusion:

Note: "M"-Meet the standard's requirement "F"-Fail to meet the standard's requirement "---"-No commentRemark:Modified content: increased CMA affirmation and CNAS accreditation marks.This report replaces test report 20R000098MO which has become invalid automatically.All the tested items are tested under the standard condition (except for indication). Copies of the report are valid only re-stamped. The experiment was carried out at No.1, Zhujiang Road, Panyu District, Guangzhou, Guangdong, P.R.China.

Standard Adopted: EN 14683:2019+AC:2019 <Medical face masks-Requirements and test methods>

Approved By:

ZiShan Guo Senior Engineer

Page 1 of 13

Test Report

Issue Date: 2020-04-23

Verification Code: ERMO-7661-44

Verification Website: www.gttc.net.cn

No:20R000098MT

Page 11: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

Test Report No: 20R000098MT

Page 2 of 13

Page 12: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Test method:

Mean particle size: 3.0 μm

Pretreatment: Condition each specimen for 4 h by exposure to a temperature of (21±5)℃ and a relative humidity of(85±5)%

Negative monitor count: <1 CFU

Flow rate: 28.3 l/minDimensions of the test specimens:15cm×15cm

Test bacteria : staphylococcus aureus ATCC 6538

Test environment temperature: 24.5℃, Relative humidity: 56.0%Culture medium: TSA agar medium Culture temperature: 37℃,Culture time: 48h

Total bacteria: 0 CFU/plate Total fungi: 0 CFU/plate Blank experiment: Aseptic growth

Autoclave

The environmental conditions of the laboratory and test condition:

Experimental system for bacterial filtration efficiency (BFE) of mask

Test equipment: IncubatorElectronic balance

Test principle: A specimen of the mask material is clamped between a six-stage cascade impactor and an aerosol chamber. An aerosolof Staphylococcus aureus is introduced into the aerosol chamber and drawn through the mask material and theimpactor under vacuum. The bacterial filtration efficiency (BFE) of the mask is given by the number of colony formingunits passing through the medical face mask material expressed as a percentage of the number of colony forming unitspresent in the challenge aerosol.

EN 14683: 2019+AC: 2019 Annex B

Test Report20R000098MT

The medical face mask in contact with the bacterial challenge: inside

Bacterial filtration efficiency (BFE)

Page 3 of 13

Page 13: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Results:

Remarks:

Requirement(%)

≥98EN 14683:2019+AC:2019

20R000098MT

2

BFE(%)

99.63

4

4

C is positive control average;T is the total plate count for the test specimen.

Page 4 of 13

75 5

where

99.74

Type ⅡR

1 4

6

Sample

B is bacterial filtration efficiency (BFE), %;

99.7999.7999.68

Conclusion

B = (C − T) / C × 100 For each test specimen calculate the bacterial filtration efficiency B, as a percentage, using the following formula:

T

Test Report

Pass

Classification

3

Page 14: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Test method:

Test principle:

Test equipment:

The environmental conditions of the laboratory and test condition:

Take the required samples from the original packaging. Weigh a certain amount of sample and placed in a sterile500 ml bottle containing 300 ml of extraction liquid (1 g/l Peptone, 5 g/l NaCl and 2 g/l Tween 20). The bottle is laiddown on an orbital shaker and shaken for 5 min at 250 rpm. After this extraction step, 100 ml of the extraction liquidis filtered through a 0.45 µm filter and laid down on a TSA plate for the total viable aerobic microbial count. Another100 ml aliquot of the same extraction liquid is filtered in the same way and the filter plated on Sabouraud Dextroseagar (SDA) for fungi enumeration. The plates are incubated for 3 days at 30℃ and 7 days at (20 to 25)℃ for TSA andSDA plates respectively. The total bioburden is expressed by addition of the TSA and SDA counts.

Constant temperature incubatorElectronic balance

Test Report20R000098MT

Microbial cleanlinessEN ISO 11737-1:2018, Membrane filtration

Pressure steam sterilizer

Test environment monitoring: total bacteria: 0 CFU/plate, total fungi: 0 CFU/plate, blank experiment: aseptic growth

Biosafety cabinet

Test environment temperature: 24.5℃, Relative humidity: 56.0%

Page 5 of 13

Page 15: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Results:

Page 6 of 13

2 EN 14683:2019+AC:2019

Microbial cleanliness(CFU/g)

Requirement(CFU/g)

Microbial Classification

Fungi

Conclusion

Test Report20R000098MT

Measured value(CFU/g)

Bacteria 1012 ≤30 Type ⅡR Pass

Page 16: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Test method:

Air flow: 8 l/min

Test Report20R000098MT

Pretreatment: Condition each specimen for a minimum of 4 h by exposure to a temperature of (21±5)℃ and a relativehumidity of (85±5)%

Page 7 of 13

This procedure was performed to evaluate the differential pressure of the medical face mask material by measuring theair exchange pressure through a measured surface area at a constant air flow rate.

EN 14683:2019+AC:2019 Annex CDifferential pressure

Test principle:

Test equipment:

The environmental conditions of the laboratory and test condition:

GTTC-YLC-1 Apparatus for measuring differential pressure

General location of the areas of the mask the differential measurements: specimen center

Page 17: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Results:

Page 8 of 13

Test Report

20.6 EN 14683:2019+AC:2019

20R000098MT

Measuredvalue(Pa)

92

Conclusion

1

Pass

Classification

Type ⅡR

Average

111102100

<602

Differential pressure Requirement

101

Sample

34

101

5

Page 18: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Test method:

Surface tension of synthetic blood: 0.042 N/m

Electronic balanceTargeting plate

The environmental conditions of the laboratory and test condition:

Test apparatus for synthetic blood penetration LFY-227Air compressorGraduated cylinder

Splash resistance pressureISO 22609:2004

Test Report20R000098MT

Test principle:A specimen medical face mask is supported on an apparatus. A volume of synthetic blood is sprayed horizontally at thespecimen mask to simulate the scenario of a mask being splashed by a punctured blood vessel. The volume of fluid,distance to impact, orifice size and fluid velocity are defined in this method and intended to be consistent with thishealth care scenario. Any evidence of synthetic blood penetration on the side of the medical face mask contacting thewearer’s face constitutes failure. Results are reported as “pass/fail” . Specimen medical face masks are evaluated at atotal of three different velocities corresponding to human blood pressures of 10.6 kPa, 16.0 kPa, and 21.3 kPa. Testresults are reported at each velocity and the medical face mask is rated at the highest corresponding blood pressure forwhich medical face mask specimens demonstrate an acceptable quality limit of 4.0.

Test equipment:

Pretreatment: Condition each specimen for 24 h by exposure to a temperature of (21±5)℃ and a relative humidity of(85±5)%

Pressure: 16.0 kPaVelocity: 550 cm/s

Page 9 of 13

Page 19: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Results:

Remarks:

pass

passpass

passpasspass

passpasspasspasspass

passpasspasspasspass

pass

passpass

pass

passpasspasspasspasspass

passpasspasspass

passpasspass

32

262728293031

202122232425

≥16.0EN 14683:2019+AC:2019

Final result

1234

131415

Sample Conclusion

Measured value

Pressure

16.0 kPa

Pass

Classification

Page 10 of 13

An acceptable quality limit of 4.0 % is met for a single sampling plan when 29 or more of the 32 tested specimensshow "pass" results.

Requirement(kPa)

Test Report20R000098MT

89

101112

19

161718

Type ⅡR

567

Page 20: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Test Method: EN 14683:2019+AC:2019 5.1.1

The medical face mask shall not disintegrate, split or tear during intended use.

Page 11 of 13

Conclusion

The medical face mask is a medical device, generally composed of a filter layer thatis placed, bonded or moulded between layers of fabric. Pass

Requirement

In the selection of the filter and layer materials, attention shall be paid tocleanliness. Pass

Pass

Test Report20R000098MT

Materials and construction

Results:

Page 21: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Test Method: EN 14683:2019+AC:2019 5.1.2

Results:

Medical face masks may have different shapes and constructions as well asadditional features such as a face shield (to protect the wearer against splashes anddroplets) with or without anti-fog function, or a nose bridge (to enhance fit byconforming to the nose contours).

Pass

The medical face mask shall have a means by which it can be fitted closely over thenose, mouth and chin of the wearer and which ensures that the mask fits closely atthe sides.

Pass

Page 12 of 13

Test Report20R000098MT

Design

Requirement Conclusion

Page 22: MASQUES MEDICAL TYPE IIRHUNAN MENDALE HOMETEXTILE CO., LTD 168 GUYUAN ROAD,LUGU INDUSTRY BASE,HI-TECH INDUSTRIAL DEVELOPMENT ZONE,CHANGSHA CITY,CHINA Bacterial filtration efficiency

TEST REPORT

No:

Test Method: EN 14683:2019+AC:2019 5.2.1

Results:

All tests shall be carried out on finished products or samples cut from finishedproducts. Pass

Page 13 of 13

Test Report20R000098MT

General

Requirement Conclusion