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Face Mask & Respirator Specifications

COVID-19 Impact: Due to increasing costs of operations during COVID-19 we are implementing a test fee surcharge. Making every effort to ensure continuity of testing operations in this unprecedented environment, we are investing significant resources to manage adjusted lab staff schedules for social distancing, training up staff in high demand areas, using additional facilities, expediting supply orders, and working weekends and overtime. Accordingly we are adding a 30% surcharge to our test fees in areas impacted by COVID-19 demand for the duration of the current crisis. Thank you for your understanding while we strive to provide essential testing services in these difficult times. We also encourage you to review our COVID-19 FDA Guidance for Face Masks and Respirators – Performance document before submitting your samples for testing.

Face Masks: For additional information regarding our Study Outline see here: https://www.nelsonlabs.com/testing/surgical-face-masks-and-general-use-masks-astm-f2100/  ; also here is a link to the FDA 510(k) document for face masks: https://www.fda.gov/media/71660/download

U.S. – ASTM F2100Test Code &

Sample Amount

Test Description

Sample Requirements

Unit Price &

Turnaround Time

BFE101CBacterial Filtration Efficiency (BFE) only$171.60 per sample
Sample Amount5 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
DPT110CDifferential Pressure for breathability$59.80 per sample
Sample Amount5 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
FTS101CFlammability Test$819.00 per set
Sample AmountMinimum of 14 replicate samples24 calendar days
PFE115CParticle Filtration Efficiency$185.90 per sample
Sample Amount5 (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
SBP210CSynthetic Blood Penetration for Face Masks$559.00 per set
Sample Amount32 masks are required for each pressure, 1 extra for setup; specify pressure when submitting samples (80, 120 or 160 mmHg)22 calendar days
CTX125Cytotoxicity: MEM elution, L929, titration method, 4 dose levels$500.00 per test
Sample Amount1 complete device 120cm2²

***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.)

14 calendar days
SCX110Sensitization: Magnusson-Kligman Method$11,450 per test
Sample Amount6 complete devices 120cm²75 calendar days
SCX220Irritation: Intracutaneous Toxicity (ISO)$2,350.00 per test
Sample Amount6 complete samples, 120cm²50 calendar days

 

European Standard – EN 14683Test Code &

Sample Amount

Test Description

Sample Requirements

Unit Price &

Turnaround Time

BFE101CBacterial Filtration Efficiency includes Diff. Pressure for breathability$171.60 per sample
Sample Amount5 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
DPT110CDifferential Pressure for breathability$59.80 per sample
Sample Amount5 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
SBP210CSynthetic Blood Penetration for Face Masks$559.00
Sample Amount32 masks are required for each pressure, 1 extra for setup; specify pressure when submitting samples (80, 120 or 160 mmHg)22 calendar days
MCM100Microbial Cleanliness for Face Masks$1,450.00
Sample AmountTest is per mask type or configuration, set of 5 samples required18 calendar days

 

Respirators:  For additional information regarding our Study Outline see here:

https://www.nelsonlabs.com/testing/respirator-pre-certification-tests-niosh/

Nelson Labs will conduct the precertification, to which you will have to then take the results to NIOSH for certification.

NIOSH – For RespiratorsTest Code &

Sample Amount

Test Description

Sample Requirements

Unit Price &

Turnaround Time

SCL110CSodium Chloride (NaCl) Challenge – screening test$206.70 per sample
Sample Amount3-5 masks48 calendar days
NRC110CSodium Chloride (NaCl)$3,562.00 per set
Sample Amount20 masks48 calendar days
NRC115CDioctyl Phthalate (DOP)$3,965.00 per set
Sample Amount20 masks48 calendar days
NRC120CInhalation and Exhalation$637.00 per set
Sample Amount3 masks20 calendar days
NRC125CValve Leak Test$637.00 per set
Sample Amount3 masks32 calendar days

Here is the NIOSH page: https://www.cdc.gov/niosh/npptl/respcertfeescheduletables.html. After our pre-certification testing, you should contact NIOSH if you would like to know turnaround times, especially during this critical time. We are not able to support with the NIOSH application at this time.

 

Additional Note for Respirators: Respirator samples are not compatible with PFE115 (Particle Filtration Efficiency: Latex Particle Challenge), flat sheets of material must be sent.

 

Ship Samples to:

Attn: Sample Login

Nelson Labs

6280 S. Redwood Rd.

Salt Lake City, UT 84123

Submitting samples:

  • Ensure the sample ID from the Sample Submission Form is clearly visible on the box or bag that masks are sent in (to prevent any delays to clarification once samples are received).  This is what will appear on your final report.
  • Provide a printed, signed and dated copy of the attached completed Sample Submission Form (to prevent any delays) in the box with your samples.  Ensure you complete a separate Sample Submission Form for each test code.
    1. PDF version of the Nelson Sample Submission Form found here: https://www.nelsonlabs.com/wp-content/uploads/2018/09/SSFGeneric.pdf
  • Ensure a copy of the Purchase Order is included within the box of samples.

 

Please note that the pricing listed above is only valid for 90 days, it does not include any additional fees such as GLP or sample return fees.  Please let us know when you’re ready to submit samples and we can provide you with a formalized quote.  When you are ready to ship samples, simply follow the submission instructions above.