Standards and Testing
Our non-medical “community” masks provide an extra layer of protection against COVID-19 as recommended by national and international health agencies. They are not FDA approved, not intended for medical use, and not a replacement for social distancing. Community face coverings are intended for use by people not displaying any clinical symptoms of viral or bacterial infection.
The World Health Organization issued guidelines on June 5, 2020 concerning non-medical community masks. The EU also published guidelines (CEN Workshop Agreement, June 2020) for community masks. Our supplier and partner, Pactics, regularly monitors published guidelines and contracts independent test labs to validate results. Below are some highlights from the WHO and EU publications.
| World Health Organization | European Union | National Facewear | |
| Particle Filtration Efficiency(PFE) | No minimums provided but references published French standards of > 70% 3.0 micron | Minimum > 70% 3.0 micon | Meets Standards. 2 layer 72% 3.0 micron (Centexbel lab test); 3 layer with disposable nonwoven meltblown filter insert 99% 0.1 micron (Nelson Lab test) 3 Layer with permanent filter is 90% PFE |
| Breathability/Air Permeability | < 1000 l/(m2.s) – converted from pa | < 960 l/(m2.s) | Meets standards. 788 l/(m2.s) (Centexbel lab test) |
| Layers | Recommend three; outer layer polyester, inner cotton and a middle hydropholic layer | Not specific as to the number of layers but recommends multiple fabrics with acceptable PFE and breathability ratings | All models have outer polyester and inner cotton. 3 layer masks adds a hydrophobic polyester filter pocket which can hold a filter to further improve PFE. New 3 layer adds nonwoven meltblown washable filter |
| Mask Shape | Fits closely over nose, cheeks and chin | Fits closely over nose, cheeks and chin | Form fitting with middle seam, elastic band, adjustable nose clip and adjustable strap creating air pocket for better breathability |
| Washing | Frequently, 140 degrees F with detergent | Frequently, 140 degrees F with detergent, minimum five washings | Washable 140 degrees F with detergent, tested up to 60 washes |
| Wear and tear | If fabric layers look noticeably worn out, discard the mask | If fabric layers look noticeably worn out, discard the mask | Durable and can undergo numerous washings without any noticeable deterioration |
| Bacterial Filtration Efficiency | Not mentioned | Not mentioned | Both models > 95% 3 micron |
| Flammability | Not Mentioned | Not Mentioned | Passed as Class 1 under NIOSH standards (SGS lab test) |
Test Article: Pactics Facewear-with-filter-28APR2020
Pactics Facewear 4-Layer with non woven melt blown filter
Purchase Order: PO-202004001
Study Number: 1291718-S01
Study Received Date: 01 May 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: Smooth Off White Side
Area Tested: 91.5 cm2
Particle Size: 0.1 µm
Laboratory Conditions: 22°C, 23% relative humidity (RH) at 0203; 22°C, 23% RH at 0327
Average Filtration Efficiency: 99.0%
Standard Deviation: 1.04
Deviation Details: Controls and sample counts were conducted for one minute instead of an average of three minutes. 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 establishing a state of stable equilibrium before sample counts are taken. Test method acceptance criteria were met, results are valid.
| Test Article Number | Test Article Counts | Average Control Counts | Filtration Efficiency (%) |
| 1-1a | 65 | 10,872 | 99.40 |
| 1-2a | 70 | 11,459 | 99.39 |
| 2 | 66 | 13,955 | 99.53 |
| 3-1a | 46 | 11,929 | 99.61 |
| 3-2a | 38 | 12,192 | 99.69 |
| 4 | 374 | 11,567 | 96.8 |
| 5 | 151 | 12,455 | 98.8 |
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. Only the investigational test results are reported/valid.
