1

Evaluation of Decontaminated N95 Respirators 

Date Tested: 1/5/2021 – 1/8/2021 

Respirator Model(s): Halyard Fluidshield 46727, 3M 1860 

Tests: Filtration with NaCl (modified version of STP-0059), Manikin Fit Factor with Static Advanced Headform, and Strap 

Integrity with Tensile Testing 

Decontamination Method: Bioquell Proteq Unit Hydrogen Peroxide Vapor (HPV) decontamination with ˃480 ppm HPV, a 

900 second dwell period, and 1,800 seconds aeration time. 

Decontamination Cycles: 5 cycles 

While decontamination and reuse of FFRs are not consistent with standard and approved usage, these options 

may need to be considered when FFR shortages exist. This assessment was developed to quantify the filtration 

efficiency and manikin fit factor1 of an N95 respirator that has been decontaminated. This assessment is not to 

determine the effectiveness of the decontamination procedure at killing pathogenic microorganisms. The results 

provided in this report are specific to the subset of samples that were provided to NPPTL for evaluation. These 

results may be used to update the CDC guidance for Crisis Capacity Strategies (during known shortages). 

Forty respirators that were unworn and not subjected to any pathogenic microorganisms were submitted for 

evaluation. This included 30 respirators that were subjected to 5 cycles of the HPV decontamination process 

and an additional 10 respirators that served as controls. Figure 1 photos document the procedures used. The 

samples were tested using a modified version of the NIOSH Standard Test Procedure (STP) TEB-APR-STP-0059 to 

determine particulate filtration efficiency. The TSI, Inc. model 8130 using sodium chloride aerosol was used for 

the filtration evaluation. For the laboratory fit evaluation, a static manikin headform was used to quantify 

changes in manikin fit factor. The TSI, Inc. PortaCount® PRO+ 8038 in “N95 Enabled” mode was used for this 

evaluation. Additionally, tensile strength testing of the straps was performed to determine changes in strap 

integrity. The Instron® 5943 Tensile Tester was used for this evaluation. The full assessment plan can be found 

here. 

Halyard 46727

Filtration Efficiency Results: The minimum and maximum filter efficiencies were 98.44% and 99.74%, 

respectively. All respirators measured filter efficiencies greater than 95%. See Table 1. 

Manikin Fit Factor Results: The manikin fit factor showed passing fit factors (≥ 100) for all respirators evaluated. 

See Table 2. 

Strap Integrity Results: The top straps showed a 4.56% increase in recorded force and the bottom straps 

showed a 4.73% increase in force. See Table 3. 

1The American Industrial Hygiene Association defines the Manikin Fit Factor as “An expression related to the amount of leakage measured through the 

face or neck seal of a respirator mounted to a manikin under specified airflow and environmental conditions. If the challenge to the seal is an airborne 

substance, it is the ratio of its airborne concentration outside the respirator divided by the concentration that enters the respirator through the seal. If the 

challenge is airflow or air pressure, conditions and assumptions for quantifying leakage must be specified. Leakage from other sources (e.g., air purifying 

elements) must be essentially zero. The respirator may be mounted to the manikin without sealants; be partially sealed to the manikin; or be sealed to the 

manikin with artificially induced leaks.” 
2

3M 1860

Filtration Efficiency Results: The minimum and maximum filter efficiencies were 98.67% and 99.37%, 

respectively. All respirators measured filter efficiencies greater than 95%. See Table 4. 

Manikin Fit Factor Results: The manikin fit factor showed passing fit factors (≥ 100) for all respirators evaluated. 

See Table 5.

Strap Integrity Results: The top straps showed a 16.18% increase in recorded force and the bottom straps 

showed a 19.22% increase in force. See Table 6.
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Figure 1. Laboratory Test Photos

Fig. 1A. Large Static Advanced Headform (Halyard 46727) Fig. 1B. Medium Static Advanced Headform (3M 1860)

Fig. 1C. TSI 8130 Filter Tester Fig. 1D. Instron 5943 Tensile Tester 

A B

C D
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Table 1. Filter Efficiency Evaluation – Halyard 46727

Notes:

• The test method utilized in this assessment is not the NIOSH standard test procedure that is used for certification

of respirators. Respirators assessed to this modified test plan do not necessarily meet the requirements of STP0059, and therefore cannot be considered equivalent to N95 respirators that were tested to STP-0059.

Respirator Model, 

Decon Method, # 

of cycles

Treated 

Sample #

Flow Rate

(Lpm)

Initial Filter 

Resistance

(mmH2O)

Initial Percent 

Leakage (%)

Maximum 

Percent 

Leakage (%)

Filter 

Efficiency 

(%)

Halyard 46727, 

Controls

Control 1 85 9.6 1.100 1.100 98.90

Control 2 85 10.3 0.870 0.874 99.13

Control 3 85 10.8 0.856 0.856 99.14

Halyard 46727, 

HPV, 5 cycles 

Min Fil Eff: 98.44%

Max Fil Eff: 99.74%

1 85 11.0 0.883 0.883 99.12

2 85 10.4 0.690 0.690 99.31

3 85 12.8 0.348 0.362 99.64

4 85 10.8 1.430 1.430 98.57

5 85 19.4 0.262 0.262 99.74

6 85 11.6 0.783 0.783 99.22

7 85 11.7 0.957 0.957 99.04

8 85 10.8 0.720 0.721 99.28

9 85 11.5 1.560 1.560 98.44

10 85 11.1 0.267 0.306 99.69
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Table 2. Manikin Fit Evaluation – Halyard 46727

Manikin Fit Factor of Decontaminated N95s

Respirator Model, 

Decon Method, # of 

cycles

Treated

Sample #

mFF Normal 

Breathing 1

mFF Deep 

Breathing

mFF Normal 

Breathing 2

Overall 

Manikin Fit 

Factor

Halyard 46727, 

Controls

Static Advanced Large 

Headform

(Lunar Studios)

Control 4 200+ 121 200+ 164

Control 5 171 86 200+ 134

Halyard 46727, HPV, 5 

cycles

Static Advanced Large 

Headform 

(Lunar Studios)

11 200+ 200+ 174 191

12 200+ 178 200+ 192

13 200+ 200+ 200+ 200+

14 200+ 60 200+ 113

15 200+ 125 189 164

Notes:

• Per OSHA 1910.134(f)(7), if the fit factor as determined through an OSHA-accepted quantitative fit testing protocol

is equal to or greater than 100 for tight-fitting half facepieces, then the fit test has been passed for that respirator.

• This assessment does not include fit testing of people and only uses two exercises (normal and deep breathing) on

a manikin headform.

• This assessment is a laboratory evaluation using a manikin headform and varies greatly from the OSHA individual

fit test. This headform testing only includes normal breathing and deep breathing on a stationary (non-moving)

headform; therefore, fit results from this assessment cannot be directly translated to using the standard OSHAaccepted test. Instead, this testing provides an indication of the change in fit performance (if any) associated with

the decontamination of respirators.

Table 3. Strap Integrity Evaluation – Halyard 46727

Tensile Force in Respirator Straps of Decontaminated N95s

(recorded force values are at 150% strain)

Respirator Model, Decon 

Method, # of cycles Straps from Treated Sample # Force in Top Strap (N)

Force in Bottom 

Strap (N)

Halyard 46727, Controls 

Control 1 2.267 2.295

Control 2 2.329 2.364

Control 3 2.372 2.312

Control Strap Average 2.323 2.324

Halyard 46727, HPV, 5 cycles 

1 2.501 2.420

2 2.442 2.404

3 2.368 2.436

4 2.406 2.477

Decontaminated Strap 

Average 2.429 2.434

% Change

((Deconned - Controls)/ 

Controls)

4.56% 4.73%
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Table 4. Filter Efficiency Evaluation – 3M 1860

Notes:

• The test method utilized in this assessment is not the NIOSH standard test procedure that is used for certification

of respirators. Respirators assessed to this modified test plan do not necessarily meet the requirements of STP0059, and therefore cannot be considered equivalent to N95 respirators that were tested to STP-0059.

Respirator Model, 

Decon Method, # 

of cycles

Treated 

Sample #

Flow Rate

(Lpm)

Initial Filter 

Resistance

(mmH2O)

Initial Percent 

Leakage (%)

Maximum 

Percent 

Leakage (%)

Filter 

Efficiency 

(%)

3M 1860, Controls 

Control 1 85 8.4 0.490 0.807 99.19

Control 2 85 9.1 0.396 0.690 99.31

Control 3 85 10.0 0.581 0.802 99.20

3M 1860, HPV, 5 

cycles 

Min Fil Eff: 98.67%

Max Fil Eff: 99.37%

1 85 8.7 0.538 0.829 99.17

2 85 8.3 0.510 0.938 99.06

3 85 9.2 0.501 0.819 99.18

4 85 8.8 0.358 0.629 99.37

5 85 9.7 0.466 0.869 99.13

6 85 9.1 0.608 0.950 99.05

7 85 8.6 0.651 1.040 98.96

8 85 8.6 0.498 0.880 99.12

9 85 8.3 0.557 0.925 99.08

10 85 10.1 1.090 1.330 98.67
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Table 5. Manikin Fit Evaluation – 3M 1860 

Manikin Fit Factor of Decontaminated N95s

Respirator Model, 

Decon Method, # of 

cycles

Treated

Sample #

mFF Normal 

Breathing 1

mFF Deep 

Breathing

mFF Normal 

Breathing 2

Overall 

Manikin Fit 

Factor

3M 1860, Controls

Static Advanced 

Medium Headform 

(Hanson Robotics)

Control 4 200+ 173 200+ 190

Control 5 200+ 200+ 200+ 200+

3M 1860, HPV, 5 

cycles 

Static Advanced 

Medium Headform 

(Hanson Robotics)

11 200+ 196 200+ 199

12 200+ 200+ 200+ 200+

13 200+ 200+ 200+ 200+

14 200+ 200+ 200+ 200+

15 200+ 200+ 200+ 200+

Notes:

• Per OSHA 1910.134(f)(7), if the fit factor as determined through an OSHA-accepted quantitative fit testing protocol 

is equal to or greater than 100 for tight-fitting half facepieces, then the fit test has been passed for that respirator.

• This assessment does not include fit testing of people and only uses two exercises (normal and deep breathing) on 

a manikin headform. 

• This assessment is a laboratory evaluation using a manikin headform and varies greatly from the OSHA individual 

fit test. This headform testing only includes normal breathing and deep breathing on a stationary (non-moving) 

headform; therefore, fit results from this assessment cannot be directly translated to using the standard OSHAaccepted test. Instead, this testing provides an indication of the change in fit performance (if any) associated with 

the decontamination of respirators. 

Table 6. Strap Integrity Evaluation – 3M 1860 

Tensile Force in Respirator Straps of Decontaminated N95s

(recorded force values are at 150% strain)

Respirator Model, Decon 

Method, # of cycles Straps from Treated Sample # Force in Top Strap (N)

Force in Bottom 

Strap (N)

3M 1860, Controls 

1 2.789 2.920

2 2.784 2.857

3 2.864 3.027

Control Strap Average 2.812 2.935

3M 1860, HPV, 5 cycles 

1 3.253 3.543

2 3.215 3.497

3 3.284 3.473

4 3.314 3.481

Decontaminated Strap 

Average 3.267 3.499

% Change 

((Deconned - Controls)/ 

Controls 

16.18% 19.22%