NPPTL COVID-19 Response: Beyond Shelf Life/Stockpiled Respirator Assessment

Manufacturer: Safe Life and TrioMed

Models Tested: Safe Life B130 (LOT # 100615), TrioMed B130 (LOT # 101115),

Safe Life B150 (LOT # 100729)

Date Tested: April 14, 2020

Report Prepared: April 15, 2020

These findings pertain to the Safe Life B130 and B150 units from the facility in Fort Detrick, Maryland.

They may not be applicable to other stockpile facilities and/or under different environmental storage 

conditions. No shelf life was designated for these models by the previously held NIOSH approval 

holder.

The TrioMed model B130 (LOT # 101115) samples passed the NIOSH filtration efficiency testing. Four 

(4) of the samples from the Safe Life model B130 (LOT # 100615) failed the NIOSH filtration efficiency 

testing. All samples from the Safe Life model B150 (LOT # 100729) failed the NIOSH filtration efficiency 

test.

Based on the filtration results provided in this report, and under the circumstances regarding the 

shortage of NIOSH-approved respirators for the COVID-19 response, it is reasonable to assume that the

TrioMed B130 products may perform as intended. NIOSH supports any requests the US Air Force 

makes to the FDA regarding the TrioMed B130 inclusion in an FDA Emergency Use Authorization.

Based on the filtration results provided in this report, and under the circumstances regarding the 

shortage of NIOSH-approved respirators for the COVID-19 response, it is unreasonable to assume that 

the Safe Life B130 and Safe Life B150 products perform as intended. NIOSH supports any requests the 

US Air Force makes to the FDA regarding the use of these products as surgical masks.

Based on prior research conducted by NIOSH and the limited testing results provided here, NIOSH does

not have enough information to definitively know the level of protection that may be provided by 

respirators that 1) are stored for prolonged periods of time; 2) are stored under various storage 

conditions; or 3) have exceeded the approval holder’s designated shelf life. Users of respirators that 

have exceeded the designated shelf life should be forewarned to avoid a false sense of confidence; 

these devices may not provide the same level of protection as those that have not exceeded the 

designated shelf life.

NIOSH regulation sets the minimum quality and performance requirements for the approval of 

respirators (42 CFR 84). NIOSH does not have requirements for shelf life or storage conditions for 

particulate-only air purifying respirators (APRs). The approval holder (i.e. the entity that is granted the 

approval from NIOSH) is responsible for understanding how their products’ design or performance may 

be affected by various use or storage conditions and must provide instruction for establishing the 

proper use, storage, and maintenance procedures for their approved products, which may include 

designating a shelf life. FFR or particulate filter packaging (such as the box) often includes NIOSHapproved user instructions, label information, and recommendations on shelf life. Additionally, some 

approval holders also disseminate recommendations related to storage and shelf life through 

resources such as user and web notices. The respirators tested in this study were generally not 

designed for long-term storage. 
NPPTL COVID-19 Response: Beyond Shelf Life/Stockpiled Respirator Assessment

The results provided in this letter are specific to the subset of previously NIOSH-approved N95s that 

were provided to NPPTL for evaluation.

These results will be added to the CDC guidance for Stockpiled N95 Filtering Facepiece Respirators 

Beyond the Manufacturer-Designated Shelf Life.
NPPTL COVID-19 Response: Beyond Shelf Life/Stockpiled Respirator Assessment

Evaluation of Stockpiled and Beyond

Manufacturer-Designated Shelf Life 95s

Test: TEB-APR-STP-0059

Date Tested: April 14, 2020

Report Prepared: April 15, 2020

Manufacturer: Safe Life

Item Tested: B130 N95 RESPIRATOR & SURGICAL MASK LOT # 100615

Expiration Date: Not Provided Manufacture Date: Not Provided

Respirator Flow Rate

Lpm

Initial Filter 

Resistance

(mm H2O)

Initial 

Penetration

(%)

Maximum 

Penetration

(%)

Filter Efficiency

1 85 7.2 5.39 5.80 94.20

2 85 8.3 5.02 5.63 94.37

3 85 10.1 2.67 2.71 97.29

4 85 8.9 2.05 2,15 97.85

5 85 8.6 1.84 1.84 98.16

6 85 7.4 4.44 5.28 94.72

7 85 10.3 1.79 1.83 98.17

8 85 8.7 2.31 2.33 97.67

9 85 11.3 2.60 2.60 97.40

10 85 8.4 4.24 4.80 95.20

11 85 7.3 9.85 10.20 89.80

12 85 8.3 1.90 2.02 97.98

13 85 9.2 2.99 3.05 96.95

14 85 8.3 2.98 3.13 96.87

15 85 9.8 2.56 2.58 97.42

16 85 10.4 2.94 2.94 97.06

17 85 8.8 3.39 3.39 96.61

18 85 8.9 2.02 2.13 97.87

19 85 10.1 3.08 3.12 96.88

20 85 9.8 4.06 4.06 95.94

Pictures have been added to the 

end of this report.
NPPTL COVID-19 Response: Beyond Shelf Life/Stockpiled Respirator Assessment

Evaluation of Stockpiled and Beyond

Manufacturer-Designated Shelf Life 95s

Test: TEB-APR-STP-0059

Date Tested: April 14, 2020

Report Prepared: April 15, 2020

Manufacturer: TrioMed

Item Tested: B130 N95 RESPIRATOR & SURGICAL MASK LOT # 101115

Expiration Date: Not Provided Manufacture Date: Not Provided

Respirator Flow Rate

Lpm

Initial Filter 

Resistance

(mm H2O)

Initial 

Penetration

(%)

Maximum 

Penetration

(%)

Filter Efficiency

1 85 15.2 0.373 0.375 99.63

2 85 13.9 0.271 0.271 99.73

3 85 12.4 0.218 0.218 99.78

4 85 11.8 0.36 0.236 99.76

5 85 12.8 0.076 0.076 99.92

6 85 14.3 0.211 0.211 99.79

7 85 12.1 0.268 0.268 99.73

8 85 16.3 0.393 0.393 99.61

9 85 12.3 0.257 0.257 99.74

10 85 14.3 0.403 0.585 99.42

11 85 11.9 0.235 0.235 99.77

12 85 12.9 0.341 0.341 99.66

13 85 12.1 0.264 0.264 99.74

14 85 13.4 0.404 0.404 99.60

15 85 12.2 0.189 0.189 99.62

16 85 13.3 0.318 0.318 99.68

17 85 14.1 0.388 0.388 99.61

18 85 12.1 0.213 0.213 99.79

19 85 13.4 0.288 0.288 99.71

20 85 13.2 0.277 0.277 99.72

Evaluation of Stockpiled and Beyond

Pictures have been added to the 

end of this report.
NPPTL COVID-19 Response: Beyond Shelf Life/Stockpiled Respirator Assessment

Manufacturer-Designated Shelf Life 95s

Date Tested: April 14, 2020

Report Prepared: April 15, 2020

Manufacturer: Safe Life

Item Tested: B150 N95 RESPIRATOR & SURGICAL MASK LOT # 100729

Expiration Date: Not Provided Manufacture Date: Not Provided

Respirator Flow Rate

Lpm

Initial Filter 

Resistance

(mm H2O)

Initial 

Penetration

(%)

Maximum 

Penetration

(%)

Filter Efficiency

1 85 6.6 8.86 10.30 89.70

2 85 8.6 6.39 6.70 93.30

3 85 5.4 7.44 8.52 91.48

4 85 9.0 6.01 6.26 93.74

5 85 12.5 8.06 8.06 91.94

6 85 11.0 12.66 12.88 87.12

7 85 10.1 12.00 12.30 87.70

8 85 11.0 7.78 7.78 92.22

9 85 11.4 10.90 11.03 88.97

10 85 13.4 7.11 7.11 92.89

11 85 11.8 11.20 11.20 88.80

12 85 7.7 12.00 12.66 87.34

13 85 9.5 9.73 10.10 89.90

14 85 11.2 14.60 14.80 85.20

15 85 9.3 6.92 7.57 92.43

16 85 10.4 11.10 11.50 88.50

17 85 11.6 13.30 13.40 86.60

18 85 10.6 11.38 11.64 88.36

19 85 10.9 10.50 12.90 87.10

20 85 10.8 12.10 12.20 87.80

Pictures have been added to the 

end of this report.
NPPTL COVID-19 Response: Beyond Shelf Life/Stockpiled Respirator Assessment
NPPTL COVID-19 Response: Beyond Shelf Life/Stockpiled Respirator Assessment
NPPTL COVID-19 Response: Beyond Shelf Life/Stockpiled Respirator Assessment