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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

Please Note: In the past, many manufacturers have submitted a minimum of 5 samples for Differential Pressure, Bacterial Filtration Efficiency, Particle Filtration Efficiency, and 14 samples for Flammability testing – historically this sample amount has been successful in getting submission approved through the FDA.  However, with recent information we have received from the FDA, manufacturers will need to provide justification on the sampling plan they have chosen. FDA is enforcing requirements for sampling as stated in the ASTM F2100 standard. Beyond the ASTM F2100 specification, the FDA has been asking manufacturers to test up to three non-consecutive lots to demonstrate lot to lot performance or justify why this was not performed.  Five samples (or 14 for Flammability) may be sufficient for periodic R&D or verification testing, however, it is not recommended for FDA submissions any longer.  For FDA submission, we recommend the most conservative route to prevent any delays and the table below is our current recommendation based on current industry trends. For additional information see, https://www.nelsonlabs.com/ansi-aami-pb70-sample-size-requirements-understanding-sampling-plans/.

 

U.S. – ASTM F2100Test Code &

Sample Amount

Test Description

Sample Requirements

Unit Price &

Turnaround Time

BFE102CBacterial Filtration Efficiency (BFE) only, ASTM F2100 sampling$178.50 per sample
Sample Amount
32 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) x 3 non-consecutive lots

AQL 4%: (32 x 3 = 96 total masks)

21 calendar days
DPT112CDifferential Pressure only, ASTM F2100 sampling$62.25 per sample
Sample Amount
32 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) x 3 non-consecutive lots

AQL 4%: (32 x 3 = 96 total masks)

18 calendar days
FTS102CFlammability Test$94.75 per sample
Sample AmountMinimum of 32 replicate samples; Each replicate sample must be a minimum of 150 mm x 150 mm in size x 3 non-consecutive lots

16 CFR Part 1610: (32 x 3 = 96 total masks)

21 calendar days
FTS103CFlammability: Test set up fee for preliminary samples$379.00 per set
Sample AmountMinimum of 4 replicate samples; Each replicate sample must be a minimum of 150 mm x 150 mm in size x 3 non-consecutive lots (same lots used for FTS102C)

(4 x 3 = 12 total masks)

21 calendar days
PFE116CParticle Filtration Efficiency: Latex Particle Challenge, ASTM F2100 sampling$193.50 per sample
Sample Amount32 (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) x 3 non-consecutive lots

AQL 4%: (32 x 3 = 96 total masks)

21 calendar days
SBP212CSynthetic Blood Penetration for Face Masks (sets of 32), per set, ASTM F2100 sampling$582.00 per set
Sample Amount32 masks are required for each pressure, 1 extra for setup; specify pressure when submitting samples (80, 120 or 160 mmHg) X 3 non-consecutive lots

ASTM F1862: (32 x 3 = 96 total masks)

18 calendar days
CTX125Cytotoxicity: MEM elution, L929, titration method, 4 dose levels$520.00 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$11,950 per test
Sample Amount6 complete devices 120cm²70 calendar days
SCX220Irritation: Intracutaneous Toxicity (ISO)$2,475.00 per test
Sample Amount6 complete samples, 120cm²40 calendar days

 

European Standard – EN 14683Test Code &

Sample Amount

Test Description

Sample Requirements

Unit Price &

Turnaround Time

BFE101CBacterial Filtration Efficiency$178.50 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)15 calendar days
DPT110CDifferential Pressure for breathability$62.25 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)12 calendar days
SBP210CSynthetic Blood Penetration for Face Masks$582.00
Sample Amount32 masks are required for each pressure, 1 extra for setup; specify pressure when submitting samples (80, 120 or 160 mmHg)12 calendar days
MCM100Microbial Cleanliness for Face Masks$1,510.00
Sample AmountTest is per mask type or configuration, set of 5 samples required18 calendar days

 

European Standard – EN 14683Test Code &

Sample Amount

Test Description

Sample Requirements

Unit Price &

Turnaround Time

CTX125Cytotoxicity: MEM elution, L929, titration method, 4 dose levels$520.00 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$11,950 per test
Sample Amount6 complete devices 120cm²70 calendar days
SCX220Irritation: Intracutaneous Toxicity (ISO)$2,475.00 per test
Sample Amount6 complete samples, 120cm²40 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$215.00 per sample
Sample Amount3-5 masks18 calendar days
NRC110CSodium Chloride (NaCl)$3,710.00 per set
Sample Amount20 masks18 calendar days
NRC115CDioctyl Phthalate (DOP)$4,130.00 per set
Sample Amount20 masks21 calendar days
NRC120CInhalation and Exhalation$663.00 per set
Sample Amount3 masks15 calendar days
NRC125CValve Leak Test$663.00 per set
Sample Amount3 masks21 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:

  • Complete a Sample Submission Form for each test code.
      • Package samples separately by test code (if possible) – this will help save time for your overall study. Test codes beginning with “BIO” and “MCM” must be packaged separately from other samples to prevent delays.
  • Confirm the “Sponsor information” portion – this is the information that will be printed on your final report (this will also be the person we reach out to for all communication related to the study (payment, questions, etc.).
  • Ensure the sample ID from the Sample Submission Form is clearly visible on the box or bag that samples are sent in (to prevent any delays with clarification once samples are received).  This is what will appear on your final report. Ensure the sample ID on your product or box matches the sample ID on the Sample Submission Form.
  • Verify the count, the “number of samples sent” and the “number of samples to test” must match how many samples we receive and the number of samples required for testing.
  • Provide a printed, signed (a typed name is not acceptable – must be signed) and dated copy of the attached completed Sample Submission Form (to prevent any delays) in the box with your samples.
  • Ensure a copy of the Purchase Order is included within the box of samples.

 

For the following tests, please download and complete the following forms

 

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 me know when you’re ready to submit samples and I can provide you with a formalized quote.  I’ve included some submission instructions for your reference when you are ready to ship samples.  We are currently experiencing a 3-5 day backlog due to high demand.

 

Best regards and we look forward to working more with you.