| 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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