Certifications

Test Aticle: Media 2; TR853102 Purchase Order: 220362 Study Number: 1183693-S01 Study Received Date: 16 May 2019 Testing Facilty: Nelson Laboratories, LLC, 6280 S. Redwood Rd, Salt Lake City, UT 84123 US A Test Procedure(s): Standard Test Protocol (STP) Number. STP0004 Rev 16 Deviation(s): None Summary: The BFE test is performed to determine the filtration efficiency of test articles by comparing the bacterial control counts upstream of the test article to the bacterial counts downstream. A suspension of Staphylococcus aureus was aerosolized using a nebulizer and delivered to the test article at a constant flow rate and fixed ai pressure. The challenge delivery was maintained at 1.7 - 2.7 x 10^3 colony forming units (CFU) with a mean particle size (MPS) of 3.0 +- 0.3 μm. The aerosols were drawn through a six- stage, viable particie, Andersen sampler for collection. This test method complies with ASTM F2101-14, Annex B, and AS4381:2015. The Deita P test is performed to determine the breathability of test articles by measuring the differential air pressure on either side of the test article using a manometer, at a constant flow rate The Delta P test was designed to comply with MIL-M-36954C, Section 4.4.1.2, and complies with AS4381:2015, 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: Side with Sticker BFE Test Area: ~40 cm^2a BFE Flow Rate: 28.3 Liters per minute (L/min) Delta P Flow Rate: 8 L/min Conditioning Parameters: 85 +- 5% relative humidity (RH) and 21 +- 5°C for a minimum of 4 hours Positive Control Average: 1.8 x 10^3 CFU Negative Monitor Count: <1 CFU MPS: 2.9μm * A small portion of the sticker was included in the test area. Study Director: Signature of Janelle Bentz Study Completion Date: 28 May 2019 Barcode : 1193693-S01 801-290-7500 | nelsonlabs.com | sales@nelsonlabs.com bsm FRT0004-0001 Rev 20 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 entiery. Subject to NL terms and conditions at www.nelsonlabs.com Results: Test Article Number: 1, Percent BFE(%): >99.9^a, Delta P (mm H2O/cm^2): 1.8, Delta P (Pa/cm^2): 18.0 Test Article Number: 2, Percent BFE(%): >99.9, Delta P (mm H2O/cm^2): 1.8, Delta P (Pa/cm^2): 18.0 Test Article Number: 3, Percent BFE(%): >99.9^a, Delta P (mm H2O/cm^2): 1.8, Delta P (Pa/cm^2): 17.2 Test Article Number: 4, Percent BFE(%): >99.9^a, Delta P (mm H2O/cm^2): 1.7, Delta P (Pa/cm^2): 17.0 Test Article Number: 5, Percent BFE(%): >99.9^a, Delta P (mm H2O/cm^2): 1.9, Delta P (Pa/cm^2): 18.6 * There were no detected colonies on any of the Andersen sampler plates for this test article. The filtration efficiency percentages were calculated using the following equation: c-1 C = Positive control average %BFE = ((C-T)/C)x100 C = Positive Control Average T = Plate count total recovered downstream of the test article Note: The plate count total is available upon request. 801-290-7500 | nelsonlabs.com | sales@nelsonlabs.com bsm FRT0004-0001 Rev 20 Page 1 of 2