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U.S. – ASTM F2100 Test Code & Sample Amount Test Description Sample Requirements Unit Price & Turnaround Time
BFE101C Bacterial Filtration Efficiency $171.60 per sample; $858.00 for 5 tests
Sample Amount 5 samples for BFE required, AQL 4% sampling plan required for ASTM F2100, minimum 5 samples up to AQL 4% required for EN 14683; each sample must be 4 x 4 inches minimum or full face mask) 32 calendar days
FTS101C Flammability Test $819.00 per set
Sample Amount Minimum of 14 replicate samples (14 samples = 1 set) 24 calendar days
PFE115C Particle Filtration Efficiency $185.90 per sample
Sample Amount Minimum of 5 (AQL 4% sampling plan required for ASTM F2100, each sample must be 5 x 5 inches (12 x 12 cm) minimum or full face mask; specify particle size when submitting samples (0.1 for ASTM F2100, 0.3, 0.5 or 1.0 micron) 42 calendar days
SBP210C Synthetic Blood Penetration for Face Masks $559.00 per set
Sample Amount 32 masks are required for each pressure, 1 extra for setup (33 Total); specify pressure when submitting samples (80, 120 or 160 mmHg) (33 samples = 1 test) 22 calendar days
Biocompatibility for medical masks under EUA Cytotoxicity test is required Sensitization and Irritation must be addressed via memo *After EUA all three tests are required for 510(K) filing
CTX125 Cytotoxicity: MEM elution, L929, titration method, 4 dose levels $500.00 per test + $325.00 GLP Fee
Sample Amount 1 complete device 120cm² ***Recommended to also include an additional “predicate” sample.  This is a comparison device as recommended by the FDA for materials that are inherently cytotoxic. (Example: could be another mask already on the market or new/original manufactured mask when conducting a cleaning/disinfection validation.) SURFACE AREA MUST BE INCLUDED ON SSF. The Lab can do the surface area calculation for an additional Fee 14 calendar days
MCM100 Microbial Cleanliness for Face Masks $1,450 per set
Sample Amount 5 samples required, Test is per mask type or configuration, 5 samples = 1 set 60 calendar days (NO STAT)

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