Face Masks ASTM F2100 Emergency FDA Acceptance

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

DPT110C

Differential Pressure for breathability

$59.80 per sample

Sample Amount

5 samples for Delta P 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)

20 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

SCX110

Sensitization: Magnusson-Kligman Method

$11,450 per test

Sample Amount

6 complete devices 120cm²

75 calendar days

SCX220

Irritation: Intracutaneous Toxicity (ISO)

$2,350.00 per test

Sample Amount

6 complete samples, 120cm²

50 calendar days