table of content · 2020. 9. 1. · nelson labs. a sotera health company sponsor: stan lee. furich....

[email protected]

MWPTFE95 Certifications & Standards

Furich Industrial Co.Ltd (Revision 3)

Table of Content Certifications

Furich Company Registration................................................................................1

Furich Factory Registration ...................................................................................2

ISO 9001:2015-Quality Management Systems .....................................................3

D-U-N-S Certificate ...............................................................................................4

Certificate of Symbol of National Quality …………………………………………….5

Made in Taiwan..................................................................................................6-7

Australia Register of Therapeutics Goods.............................................................8

Certificate of Registration FDA...............................................................................9

Awards

2019 Bronze award in the Epidemic Prevention Category...............................10

Standards Achieved

Australia

AS 4381:2015 Level 3 (AUS&NZ)

Test Reports

ASTM F2101 BFE % ...........................................................11-12

EN14683 Differential Pressure (Delta P)..............................11-12

FDA GMP reg. 21 CFR Parts 210,211 & 820

Flammability ........................................................................17-18

F1862, ISO 22609 Synthetic blood.................................... 15-16

U.S.A

ASTM F2100-19 level 3

Test Reports

ASTM F2101 BFE % ..........................................................11-12

EN 14683 Differential pressure (Delta P) ...........................11-12

ASTM F2299 PFE % Latex Particle Challenge ..................13-14

F1862, ISO 22609 Synthetic blood ....................................15-16

FDA GMP reg. 21 CFR Parts 210,211 & 820

Flammability ........................................................................17-18

Europe

EN 14683:2019 Type IIR

Test Reports

ASTM F2101 BFE % ..........................................................11-12

EN 14683 Differential pressure (Delta P) ................................13

ASTM F2299 PFE % Latex Particle Challenge .......................14

ISO 11737-1 Microbial Cleanliness.....................................19-20

F1862, ISO 22609 Synthetic blood ....................................15-16

Taiwan-

CNS 14755

Test Reports

CNS 14755 – 0.075μm NaCl, CMD........................................21

Certification

CNS 14755 ............................................................................ 22

CNS 14774

Certification

CNS 14774 ........................................................................... 23

Material Safety

SGS Material Safety.........................................................24-27

TTRI (Taiwan Textile Research Institute)

Material Safety..................................................................28-29

Patents

Certificate M483095..................................................................................30

Certificate M551503..................................................................................31

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Australian Register of Therapeutic Goods CertificateIssued to

Airllo Pty Ltdfor approval to supply

Airllo Pty Ltd - Mask, surgical, reusableARTG Identifier 336422ARTG Start Date 15/05/2020Product Category Medical Device Included Class 1GMDN 37713GMDN Term Mask, surgical, reusableIntended Purpose A vertical flat-fold mask designed to be placed over the mouth and/or

nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of Polypropylene and ePTFE membrane material and is secured using two flat elastic ear tapes; it incorporates a forming nosepiece (PE plastic nose wire).This is a single use device.

Manufacturer Details Address Certificate number(s)

Furich Industrial Co Ltd Floor 10 No 111 Xiyuan Road Zhongli District , TaoyuanCity , Taiwan

ARTG Standard ConditionsThe above Medical Device Included Class 1 has been entered on the Register subject to the followingconditions:· - The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or

imposed on the ARTG entry. Refer Part 4-5, Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for relevant information.- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence; and civil penalties may apply.

Products Covered by This Entry1. Mask, surgical, reusable

Product Specific ConditionsNo specific conditions have been recorded against this entry.

Therapeutic Goods Administration PO Box 100, Woden ACT 2606 Australia Phone: 1800 020 653 Email: [email protected]

ARTG Identifier: 336422 ARTG Start Date: 15/05/2020

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Certificate of Registration

This certificate of Registration certifies that: Furich Industrial Co., LTD

10F., No. 111, Xiyuan Rd., Zhongli Dist., Taoyuan City, 320, Taiwan has registered with the US Food and Drug Administration pursuant to Title 21 of the United States Code of Federal Regulations.

Owner Operator Number: 10074860

Listed Device QKR D406312 Face Mask (except N95) MSH D406313 Respirator, Surgical

US Agent: Willow Glen Consultancy LLC Willow Glen Number: WG2071271 Expiration Date: December 31, 2020

This certificate affirms that the above-named facility is registered with the US FDA pursuant to the regulations required by the US laws. This registration has been verified as effective by Willow Glen Consultancy as of the date below, unless such registration has been terminated after issuance of this Certificate. Willow Glen Consultancy makes no additional representations or warranties, nor does this certificate carry any to any person or entity other than the named certificate holder, for whose sole benefit it is issued. Willow Glen Consultancy assumes no liability to any person or entity in connection with the foregoing, nor does the U.S. FDA recognize a certificate of registration issued by Willow Glen Consultancy.

Willow Glen Consultancy is a private agent not affiliated with the U.S. Food and Drug Administration.

Amanda Ou, Operation Director WillowGlenFDA.com Willow Glen Consultancy LLC [email protected] +1-619-869-0249 3755 Avocado Blvd, Suite 208 Date: June 1, 2020 La Mesa, CA 91941, USA

9

Nelson Labs.A Sotera Health company

Sponsor:Stan Lee

Furich

Floor 10, No. Ill, Xiyuan RoadZhongli District

Taoyuan City, 320TAIWAN

Bacterial Filtration Efficiency (BFE)and Differential Pressure (Delta P) Final Report

Test Article

Study NumberStudy Received Date

Testing Facility

Test Procedure(s):Deviation(s):

MWPTFE95

1283849-S01

01 Apr 2020Nelson Laboratories, LLC6280 S. Redwood Rd.Salt Lake City, UT 84123 U.S.A.Standard Test Protocol (STP) Number: STP0004 Rev 18None

Summary: The BFE test is performed to determine the filtration efficiency of test articles by comparingthe bacterial control counts upstream of the test article to the bacterial counts downstream. A suspensionof Staphylococcus aureus was aerosolized using a nebulizer and delivered to the test article at a constantflow rate and fixed air pressure. The challenge delivery was maintained at 3.5 x 10^ colony forming units(CFU) with a mean particle size (MPS) of 3.0 ± 0.3 pm. The aerosols were drawn through a six-stage,viable particle, Andersen sampler for collection. This test method complies with ASTM F2101-19 andEN 14683:2019, Annex B; with the exception of the higher challenge level, which may represent a moresevere test.

The Delta P test is performed to determine the breathability of test articles by measuring the differentialair pressure on either side of the test article using a manometer, at a constant flow rate. The Delta P testcomplies with EN 14683:2019, Annex C and ASTM F2100-19.

All test method acceptance criteria were met. Testing was performed in compliance with US FDA goodmanufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.

The positive control average was out of specification per STP0004 Rev 18 section 6.1 which states, "TheBFE positive control average shall be maintained at 1.7-3.0 x 10^ CFU." Testing with a more severechallenge to the test articles represents a worse case. The sponsor accepted the use of the higherchallenge; therefore, the results are considered valid at the testing conditions that occurred.

Test Side:

BFE Test Area:

BFE Flow Rate:

Delta P Flow Rate:Conditioning Parameters:Test Article Dimensions:

Positive Control Average:Negative Monitor Count:

MPS:

Inside

~40 cm^28.3 Liters per minute (L/min)8 L/min85 ± 5% relative humidity (RH) and 21 ± 5° C for a minimum of 4 hours~188 mm x -150 mm

3.5 X 10'

•0) Nelson Labs^ A Sotera Health company

Study Number 1283849-801Bacterial Filtration Efficiency (BFE)

and Differential Pressure (Delta P) Final Report

Results:

Test Article Number

1

2

3

4

5

Percent BFE (%)

99.8

99.7

99.8

99.9

99.9

Test Article Number

1

2

3

4

5

Delta P (mm H20/cm )4.2

4.4

4.7

4.4

4.2

Delta P (Pa/cm )

40.8

42.8

46.3

43.3

41.6

The filtration efficiency percentages were calculated using the following equation;C = Positive control average

% BFE = - - X 100 T = Plate count total recovered downstream of the test articleC Note: The plate count total is available upon request

801-290-7500 | nelsonlabs.com | [email protected] FRT0004-0001 Rev 22Page 2 of 2

12

Sponsor: Stan Lee

Furich Floor 10, No. 111, Xiyuan Road

Zhongli District Taoyuan City, 320

TAIWAN

Sarah Guzman electronically approved for

23 Jun 2020 19:03 (+00:00) Study Director Curtis Gerow Study Completion Date and Time

801-290-7500 | nelsonlabs.com | [email protected]

hcb FRT0005-0001 Rev 6 Page 1 of 2

These results apply to the samples as received and relate only to the test article listed in this report. Reports may not be reproduced except in their entirety. Subject to NL terms and conditions at www.nelsonlabs.com.

Latex Particle Challenge Final Report

Test Article: MWPTFE95

Study Number: 1294770-S01 Study Received Date: 30 Apr 2020

Testing Facility: Nelson Laboratories, LLC 6280 S. Redwood Rd. Salt Lake City, UT 84123 U.S.A.

Test Procedure(s): Standard Test Protocol (STP) Number: STP0005 Rev 07 Deviation(s): Quality Event (QE) Number(s): QE22125

Summary: This procedure was performed to evaluate the non-viable particle filtration efficiency (PFE) of the test article. Monodispersed polystyrene latex spheres (PSL) were nebulized (atomized), dried, and passed through the test article. The particles that passed through the test article were enumerated using a laser particle counter. A one-minute count was performed, with the test article in the system. A one-minute control count was performed, without a test article in the system, before and after each test article and the counts were averaged. Control counts were performed to determine the average number of particles delivered to the test article. The filtration efficiency was calculated using the number of particles penetrating the test article compared to the average of the control values. The procedure employed the basic particle filtration method described in ASTM F2299, with some exceptions; notably the procedure incorporated a non-neutralized challenge. In real use, particles carry a charge, thus this challenge represents a more natural state. The non-neutralized aerosol is also specified in the FDA guidance document on surgical face masks. All test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.

Test Side: White Side (Inside)

Area Tested:

91.5 cm2 Particle Size: 0.1 µm

Laboratory Conditions: 20°C, 32% relative humidity (RH) at 0955; 20°C, 32% RH at 1106; 21°C, 32% RH at 1253; 21°C, 31% RH at 1408;

Average Filtration Efficiency: >99.3762% Standard Deviation: 0.85388

13

Study Number 1294770-S01 Latex Particle Challenge Final Report

801-290-7500 | nelsonlabs.com | [email protected] hcb FRT0005-0001 Rev 6

Page 2 of 2

Deviation Details: Controls and sample counts were conducted for one minute instead of an average of three one minute counts. This change shortens the total test time for each sample but will still provide an accurate determination of the particle counts. An equilibrate is a dwell period where the challenge is being applied to the test article for a certain period of time before test article counts are counted. The equilibrate period was reduced from 2 minutes to a minimum of 30 seconds which is sufficient time to clear the system of any residual particles, and establish a state of stable equilibrium before sample counts are taken. Test method acceptance criteria were met, results are valid.

Results: Test Article Number Test Article Counts Average Control Counts Filtration Efficiency (%)

1-1a 212 11,463 98.2

1-2a 99.9974

2 99.9972

3b 188 11,686 98.4

3-1b 205 13,798 98.5

3-2b 1 12,319 99.9919

4 4 13,131 99.970

5 99.9974 a The original result for this test article was unexpected when compared to the other test articles. Investigational testing was performed on the same test article in duplicate and it was determined that the original result was invalid. All valid test results are reported. b The original result for this test article was unexpected when compared to the other test articles. Investigational testing was performed on the same test article in duplicate and it was determined that the original result was valid. All valid test results are reported.

14

Nelson Labs^ A Sotera Health company

Sponsor:Stan Lee

Furich

Floor 10, No. Ill, Xiyuan RoadZhongli District


Synthetic Blood Penetration Resistance Final Report

Test Article:

Study Number:Study Received Date:

Testing Facility:

Test Procedure(s):Deviation(s):

MWPTFE95

1283851-S01

01 Apr 2020Nelson Laboratories, LLC6280 S. Redwood Rd.

Salt Lake City, UT 84123 U.S.A.Standard Test Protocol (STP) Number: STP0012 Rev 09None

Summary: This procedure was performed to evaluate surgical facemasks and other types of protectiveclothing materials designed to protect against fluid penetration. The purpose of this procedure is tosimulate an arterial spray and evaluate the effectiveness of the test article in protecting the user frompossible exposure to blood and other body fluids. The distance from the target area surface to the tip ofthe cannula is 30.5 cm. A test volume of 2 mL of synthetic blood was employed using the targeting platemethod.

This test method was designed to comply with ASTM F1862 and ISO 22609 (as referenced inEN 14683:2019 and AS4381:2015) with the following exception: ISO 22609 requires testing to beperformed in an environment with a temperature of 21 ± 5° C and a relative humidity of 85 ± 10%. Instead,testing was performed at ambient conditions within one minute of removal from the environmentalchamber held at those parameters.


Number of Test Articles Tested:Number of Test Articles Passed:

Test Side:Pre-Conditioning:Test Conditions:

32

32

Outside

Minimum of 4 hours at 21 ± 5° C and 85 + 5% relative humidity (RH)20.2° C and 22% RH

Results: Per ASTM F1862 and ISO 22609, an acceptable quality limit of 4.0% is met for a normal singlesampling plan when >29 of 32 test articles show passing results.

Test Pressure: 160 mmHg (21.3 kPa)

Test Article Number

1-32

Synthetic Blood Penetration

None Seen

Study Director

CCREDITEO

TESTING LASOfUTORV

James W. Luskin Study Completion Date

llilllllllllllillll1283851-801

801-290-7500 | nelsonlabs.com | [email protected] myf FRT0012-0002 Rev 13Page 1 of 1


15

Nelson Labs.A Sotera Health company

Sponsor:Stan Lee

Furich

Floor 10, No. 111, Xiyuan RoadZhongli District


Synthetic Blood Penetration Resistance Final Report

Test Article

Study NumberStudy Received Date

Testing Facility

Test Procedure(s):

MWPTFE95

1283850-S01

01 Apr 2020Nelson Laboratories, LLC6280 S. Redwood Rd.

Salt Lake City, UT 84123 U.S.A.Standard Test Protocol (STP) Number: STP0012 Rev 09

Deviation(s): None

Summary: This procedure was performed to evaluate surgical facemasks and other types of protectiveclothing materials designed to protect against fluid penetration. The purpose of this procedure is tosimulate an arterial spray and evaluate the effectiveness of the test article in protecting the user frompossible exposure to blood and other body fluids. The distance from the target area surface to the tip ofthe cannula is 30.5 cm. A test volume of 2 mL of synthetic blood was employed using the targeting platemethod.

This test method was designed to comply with ASTM F1862 and ISO 22609 (as referenced inEN 14683:2019 and AS4381:2015) with the following exception: ISO 22609 requires testing to beperformed in an environment with a temperature of 21 ± 5° C and a relative humidity of 85 ± 10%. Instead,testing was performed at ambient conditions within one minute of removal from the environmentalchamber held at those parameters.


Number of Test Articles Tested:Number of Test Articles Passed:

Test Side:

Pre-Conditioning:Test Conditions:

32

31

Outside

Minimum of 4 hours at 21 ± 5° C and 85 ± 5% relative humidity (RH)20.6° G and 22% RH

Results: Per ASTM F1862 and ISO 22609, an acceptable quality limit of 4.0% is met for a normal singlesampling plan when >29 of 32 test articles show passing results.

Test Pressure: 120 mmhg (16.0 kPa)

Test Article Number

1-13, 15-32

14

Synthetic Blood Penetration

None Seen

Yes

CCREDITEO

TESTINO LASOHATORY

firrStudy Director

1283850-S01

801-290-7500 | nelsonlabs.com j [email protected]

James W. Luskin Study Completion Dately CcY 10 Id

FRT0012-0002 Rev 13

Page 1 of 1


16

Nelson Labs.Sponsor:Stan Lee

, , FurichA Sotera Health company i q, No. 111, Xiyuan RoadZhongli District


Flammability of Clothing Textiles Final Report

Test Article: MWPTFE95Study Number: 1283848-S01

Study Received Date: 01 Apr 2020Testing Facility: Nelson Laboratories, LLC

6280 S. Redwood Rd.Salt Lake City, UT 84123 U.S.A.

Test Procedure(s): Standard Test Protocol (STP) Number: STP0073 Rev 06Customer Specification Sheet (CSS) Number: 202001933 Rev 01

Deviation(s): None

Summary: This procedure was performed to evaluate the flammability of plain surface clothing textilesby measuring the ease of ignition and the speed of flame spread. The parameter of time is used toseparate materials into different classes, thereby assisting in a judgment of fabric suitability for clothingand protective clothing material. The test procedure was performed in accordance with the test methodoutlined in 16 CFR Part 1610 (a) Step 1 - testing in the original state. Step 2 - Refurbishing and testingafter refurbishing, was not performed. All test method acceptance criteria were met. Testing wasperformed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210,211 and 820.

Test Article Side Tested: Outside SurfaceOrientation: Perpendicular to Seam

Test Criteria for Specimen Classification (See 16 CFR Part 1610.7): ^Plain .QMrfaroToYtilp Fahrin I

1 Burn time ̂ 3.5 seconds

2 Not applicable to plain surface textile fabrics "tit |3 Burn time

x!^ Nelson Labs^ A Sotera Health company

Study Number 1283848-801Flammability of Clothing Textiles Final Report

Results:

Replicate Number1

2

3

4

5

IBE = Test Article ignited, but extinguished

Time of Flame SpreadIBE

IBE

IBE

IBE

BE

801-290-7500 | nelsonlabs.com [email protected] hmm FRT0073-0001 Rev 9Page 2 of 2

18

Sponsor: Stan Lee

Furich Floor 10, No. 111, Xiyuan Road

Zhongli District Taoyuan City, 320

TAIWAN

Kami Collet electronically approved for

16 Apr 2020 00:02 (+00:00) Study Director Robert Putnam Study Completion Date and Time

801-290-7500 | nelsonlabs.com | [email protected]

pv FRT0036-0010 Rev 10 Page 1 of 2


Microbial Cleanliness (Bioburden) of Medical Masks Final Report

Test Article: MWPTFE95

Study Number: 1283853-S01 Study Received Date: 01 Apr 2020

Testing Facility: Nelson Laboratories, LLC 6280 S. Redwood Rd. Salt Lake City, UT 84123 U.S.A.

Test Procedure(s): Standard Test Protocol (STP) Number: STP0036 Rev 15 Customer Specification Sheet (CSS) Number: 202001844 Rev 01

Deviation(s): None Summary: The testing was conducted in accordance with EN 14683:2019, with the exception of approximate volumes of eluent used when performing the extraction procedure and a temperature range of 30-35°C used for aerobic incubation. When bioburden results are calculated using a software program, manual calculations may differ slightly due to rounding. The counts determined on products are colony forming units and may not always reflect individual microorganisms. The sponsor performs any statistical analysis and determines the acceptable limits. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820. Results:

Unit Number Weight (g) Aerobic Fungal Total

Bioburden (CFU/mask)

Total Bioburden (CFU/g)

1 3.0

Study Number 1283853-S01 Microbial Cleanliness (Bioburden) of Medical Masks Final Report

801-290-7500 | nelsonlabs.com | [email protected] pv FRT0036-0010 Rev 10

Page 2 of 2

Method Suitability: Organism Percentage

Bacillus atrophaeus 108% Test Method Acceptance Criteria: If applicable, anaerobic controls are acceptable for the bioburden test results. The number of masks to be tested shall be a minimum of 5 or more to meet an acceptable quality level of 4%. The bioburden of the medical mask shall be < 30 CFU/g tested. Procedure:

Positive Controls/Monitors: Bacillus atrophaeus Extract Fluid:

Peptone Tween® Extract Fluid Volume: ~300 mL

Extract Method: Orbital Shaking for 15 minutes at 250 rpm Plating Method: Membrane Filtration

Agar Medium: Potato Dextrose Agar Tryptic Soy Agar

Recovery Efficiency: Exhaustive Rinse Method Aerobic Bacteria: Plates were incubated 3 - 7 days at 30-35°C, then enumerated.

Fungal: Plates were incubated 5 - 7 days at 20-25°C, then enumerated.

20

Dec.25,2019

NIL1PC (P2/4)

Dec.16,2019

林小芬#112 (03-4351923)

TAG8L224

Mask

┌───────────────────────┬────────────────────┬────────────┐　　　│Test　 Items　　　　　　　　　　　　　　　　　│　　　　　　　Test Results　　　　　　　│Test Methods　　　　　　│　　　├─────────────────┬─────┼────────────────────┼────────────┤　　　│Protection Efficiency　　　　　　 │1　　　　 │　　　　　　　　 99.71　　　　　　　　　│CNS 14755 Z2125-2011　　│　　　│　　　　　　　　　　　　　　　　　├─────┼────────────────────┤　　　　　　　　　　　　│　　　│of Mask(%)　　　　　　　　　　　　│2　　　　 │　　　　　　　　 99.74　　　　　　　　　│Flow rate:85.3　　　　　│　　　│　　　　　　　　　　　　　　　　　├─────┼────────────────────┤　　　　　　　　　　　　│　　　│(0.075μm NaCl,CMD)　　　　　　　 │3　　　　 │　　　　　　　　 99.79　　　　　　　　　│(Liter/min)　　　　　　 │　　　│　　　　　　　　　　　　　　　　　├─────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　│4　　　　 │　　　　　　　　 99.69　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　├─────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　│5　　　　 │　　　　　　　　 99.81　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　├─────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　│6　　　　 │　　　　　　　　 99.74　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　├─────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　│7　　　　 │　　　　　　　　 99.58　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　├─────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　│8　　　　 │　　　　　　　　 99.76　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　├─────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　│9　　　　 │　　　　　　　　 99.22　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　├─────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　│10　　　　│　　　　　　　　 99.76　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　├─────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　　　　　　　　　　　　　│Ave.　　　│　　　　　　　　 99.68　　　　　　　　　│　　　　　　　　　　　　│　　　└─────────────────┴─────┴────────────────────┴────────────┘　　　　Note: Sample description is given by the client: Airllo Film Mask　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　 20191202 dark blue　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　

Furich Industrial Co., Ltd.(U1946)

10F., No.111, Xiyuan Rd., Zhongli Dist., Taoyuan City 320, Taiwan (R.O.C.)

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22

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21

Dec.30,2019

NIL1PC (P1/2)

Dec.16,2019

林小芬#112 (03-4351923)

TAG8L224-A

Mask

┌───────────────────────┬────────────────────┬────────────┐　　　│　　　　　　　　　　　　　　　　　　　　　　　│　　　　　　　Test Results　　　　　　　│　　　　　　　　　　　　│　　　│Test　 Items　　　　　　　　　　　　　　　　　├────────────────────┤Test　Methods　　　　　 │　　　│　　　　　　　　　　　　　　　　　　　　　　　│　　　　　　 Non-Polyester　　　　　　　│　　　　　　　　　　　　│　　　├─────┬─────────────────┼────────────────────┼────────────┤　　　│*AZO DYES │4-AMINODIPHENYL　　　　　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│CNS 15980 Z3039-2017 8.7│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│(mg/kg)　 │BENZIDINE　　　　　　　　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│CNS 15205-1 L3267-1-2008│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│4-CHLORO-O-TOLUIDINE　　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│GC-MS　　　　　　　　　 │　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│2-NAPHTHYLAMINE　　　　　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│o-AMINOAZOTOLUENE　　　　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│2-AMINO-4-NITROTOLUENE　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│P-CHLOROANILINE　　　　　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│2,4-DIAMINOANISOLE　　　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│4,4'-DIAMINODIPHENYLMETHANE　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│3,3'-DICHLOROBENZIDINE　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│3,3'-DIMETHOXYBENZIDINE　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│3,3'-DIMETHYLBENZIDINE　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│3,3'-DIMETHYL-4,4'-DIAMINO-　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│.　　　　 │　DIPHENYLMETHANE　　　　　　　　 │　　　　　　　　　　　　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│P-CRESIDINE　　　　　　　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│4,4'-METHYLENE-BIS-　　　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│.　　　　 │　(2-CHLOROANILINE)　　　　　　　 │　　　　　　　　　　　　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│4,4'-OXYDIANILINE　　　　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│4,4'-THIODIANILINE　　　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│O-TOLUIDINE　　　　　　　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│2,4-TOLUYLENEDIAMINE　　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│2,4,5-TRIMETHYLANILINE　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│2-METHOXYANILINE　　　　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│P-AMINOAZOBENZENE　　　　　　　　 │　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│2,4-XYLIDINE　　　　　　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　│　　　　　├─────────────────┼────────────────────┤　　　　　　　　　　　　│　　　│　　　　　│2,6-XYLIDINE　　　　　　　　　　　│　　　　　　　　　N.D.　　　　　　　　　│　　　　　　　　　　　　│　　　└─────┴─────────────────┴────────────────────┴────────────┘　　　　Note: "*"Subcontracted test.　Note: N.D.=Not Detected.(

Dec.30,2019

NIL1PC (P2/2)

Dec.16,2019

林小芬#112 (03-4351923)

TAG8L224-A

MaskFurich Industrial Co., Ltd.(U1946)

10F., No.111, Xiyuan Rd., Zhongli Dist., Taoyuan City 320, Taiwan (R.O.C.)

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table of content · 2020. 9. 1. · nelson labs. a sotera health company sponsor: stan lee. furich....

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