sponsor: nelson labs. cathy yu ^ a sotera health company · songshan lake science & technology...

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Nelson Labs. ^ A Sotera Health company Sponsor: Cathy Yu Dongguan LIFAair Technology Limited No.2 East Industry Road, Songshan Lake Science & Technology Industrial Park Dongguan, 523808 CHINA Sodium Chloride (NaCI) Aerosol Test Final Report Test Article: Purchase Order: Study Number: Study Received Date: Testing Facility: Test Procedure(s): Deviation(s): Product title: air purifying respirator Lot#100000328822 Filtering face piece air purifying respirator for protections against particulates at a N95 filter efficiency level. Product model:LM991 LIFAair202002 1269097-S01 19 Feb 2020 Nelson Laboratories, LLC 6280 S. Redwood Rd. Salt Lake City, UT 84123 U.S.A. Standard Test Protocol (STP) Number: STP0014 Rev 09 None Summary: This procedure was performed to evaluate the particle penetration and airflow resistance properties of filtration materials. A neutralized, poly-dispersed aerosol of sodium chloride (NaCI) was generated and passed through the test article. The performance of the test article was assessed by measuring the concentration of salt particles penetrating the test article compared to the challenge concentration entering the test article. The filtration performance and airflow resistance of each test article were calculated. The filter tester used in testing was a TSI® CERTITEST® Model 8130 Automated Filter Tester that is capable of efficiency measurements of up to 99.999%. it produced a particle size distribution with a count median diameter of 0.075 ± 0.020 microns (pm) and a geometric standard deviation not exceeding 1.86 pm. The mass median diameter was approximately 0.26 pm, which is generally accepted as the most penetrating aerosol size. 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. Area Tested: Airflow Rate: Test Side: Test Type: Conditioning Parameters: Entire Respirator 85 ± 4 liters per minute (L/min) Outside Load Testing (Load Amount: 200 mg/m') 38 ± 2.5°G, 85 ± 5% relative humidity (RH) for 25 ± 1 hour ''"a ACCREDITED O,/ C//AtXjX TESTING LABOftATOfTV 7^ U 1 OtJL Study Director 1269097-801 801-290-7500 | nelsonlabs.com | [email protected] Curtis Gerow, B.S. Study Completion Date FRT0014-0001 Rev 7 Page 1 of 2 These resells 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 vtww.nelsonlabs.com.

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Page 1: Sponsor: Nelson Labs. Cathy Yu ^ A Sotera Health company · Songshan Lake Science & Technology Industrial Park Dongguan, 523808 CHINA Sodium Chloride (NaCI) Aerosol Test Final Report

Nelson Labs.^ A Sotera Health company

Sponsor:Cathy Yu

Dongguan LIFAair Technology LimitedNo.2 East Industry Road,

Songshan Lake Science & TechnologyIndustrial Park

Dongguan, 523808CHINA

Sodium Chloride (NaCI) Aerosol Test Final Report

Test Article:

Purchase Order:

Study Number:Study Received Date:

Testing Facility:

Test Procedure(s):Deviation(s):

Product title: air purifying respiratorLot#100000328822

Filtering face piece air purifying respirator for protections against particulatesat a N95 filter efficiency level.Product model:LM991

LIFAair202002

1269097-S01

19 Feb 2020

Nelson Laboratories, LLC6280 S. Redwood Rd.

Salt Lake City, UT 84123 U.S.A.Standard Test Protocol (STP) Number: STP0014 Rev 09None

Summary: This procedure was performed to evaluate the particle penetration and airflow resistanceproperties of filtration materials. A neutralized, poly-dispersed aerosol of sodium chloride (NaCI) wasgenerated and passed through the test article. The performance of the test article was assessed bymeasuring the concentration of salt particles penetrating the test article compared to the challengeconcentration entering the test article. The filtration performance and airflow resistance of each testarticle were calculated.

The filter tester used in testing was a TSI® CERTITEST® Model 8130 Automated Filter Tester that iscapable of efficiency measurements of up to 99.999%. it produced a particle size distribution with a countmedian diameter of 0.075 ± 0.020 microns (pm) and a geometric standard deviation not exceeding1.86 pm. The mass median diameter was approximately 0.26 pm, which is generally accepted as themost penetrating aerosol size. All test method acceptance criteria were met. Testing was performed incompliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and820.

Area Tested:

Airflow Rate:

Test Side:

Test Type:Conditioning Parameters:

Entire Respirator

85 ± 4 liters per minute (L/min)Outside

Load Testing (Load Amount: 200 mg/m')38 ± 2.5°G, 85 ± 5% relative humidity (RH) for 25 ± 1 hour

' '"a

ACCREDITED

O,/

C//AtXjXTESTING LABOftATOfTV

7^ U 1OtJL

Study Director

1269097-801

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

Curtis Gerow, B.S. Study Completion Date

FRT0014-0001 Rev 7

Page 1 of 2

These resells 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 vtww.nelsonlabs.com.

Page 2: Sponsor: Nelson Labs. Cathy Yu ^ A Sotera Health company · Songshan Lake Science & Technology Industrial Park Dongguan, 523808 CHINA Sodium Chloride (NaCI) Aerosol Test Final Report

•^1 Nelson Labs^ A Sotera Health company

Study Number 1269097-801Sodium Chloride (NaCI) Aerosol Test Final Report

Results:

Test Article Number

1

2

3

Corrected Initial Airflow

Resistance

(mm H2O)

9.8

9.5

10.2

Maximum Particle

Penetration

(%)

1.04

0.820

0.721

Filtration Efficiency(%)

98.96

99.180

99.279

® The final airflow resistance value for each test article was determined by subtracting out the backgroundresistance from the system.

801-Z90-7500 nelsonlabs.com | [email protected] 4.0001 Rev 7

Page 2 of 2

Page 3: Sponsor: Nelson Labs. Cathy Yu ^ A Sotera Health company · Songshan Lake Science & Technology Industrial Park Dongguan, 523808 CHINA Sodium Chloride (NaCI) Aerosol Test Final Report
Page 4: Sponsor: Nelson Labs. Cathy Yu ^ A Sotera Health company · Songshan Lake Science & Technology Industrial Park Dongguan, 523808 CHINA Sodium Chloride (NaCI) Aerosol Test Final Report

Nelson Labs.A Sotera Health company

Study Number 1275787-801Determination of Inhalation and Exhalation Resistance

for Air-Purifying Respirators Final Report

Results:

Test Article Number

1

2

3

Inhalation Resistance (mm H2O) | Exhalation Resistance (mm H2O)

7.4

7.5

8.7

7.0

7.1

7.5

Test Method Acceptance Criteria: The resistance measurement for the reference plate must be within± 3 standard deviations of the mean established in the control chart.

Procedure: A complete respirator was mounted to a test fixture comprised of a metal plate with anapproximate 3.5 inch diameter hole in the center to allow airflow to reach the mask. The sample holderwas assembled by placing a Plexiglas collar around the test fixture and topping with another metal discwith a 3.5 inch opening in the center. The sample holder is held tightly together with clamps andconnected to an air source. The manometer is attached to the sample holder by a connection port on thePlexiglas collar.

Before testing, the manometer was zeroed and the back pressure in the sample holder checked andverified to be acceptable. Resistance measurements were taken with a manometer capable of measuringat least 6 inches of water. For inhalation testing, a negative airflow (vacuum) was applied. For exhalationtesting, a positive airflow (compressed air) was used. Airflow was passed through the sample holder atapproximately 85 ± 2 liters per minute (L/min).

801-290-7500 nelsonlabs.com | [email protected] FRT0145-0001 Rev 3

Page 2 of 2