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Face Mask & Respirator Specifications

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 CodeTest DescriptionUnit Price/Turnaround Time
BFE110Bacterial Filtration Efficiency includes Diff. Pressure for breathability$155.00 per sample
Sample Amount10 (5 separate samples for BFE and 5 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
FTS101Flammability Test$630.00 per set
Sample AmountMinimum of 14 replicate samples14 calendar days
PFE115Particle Filtration Efficiency$143.00 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)12 calendar days
SBP210Synthetic Blood Penetration for Face Masks$430.00 per set
Sample Amount32 masks are required for each pressure, 1 extra for setup; specify pressure when submitting samples (80, 120 or 160 mmHg)10 calendar days
CTX115Cytotoxicity: MEM elution$255.00 per test
Sample Amount1 complete device 120cm2²13 calendar days
SCX110Sensitization: Magnusson-Kligman Method$11,450 per test
Sample Amount6 complete devices 120cm²61 calendar days
SCX220Irritation: Intracutaneous Toxicity (ISO)$2,350.00 per test
Sample Amount6 complete samples, 120cm²40 calendar days

 

European Standard – EN 14683

Test CodeTest DescriptionUnit Price/Turnaround Time
BFE110Bacterial Filtration Efficiency includes Diff. Pressure for breathability$155.00 per sample
Sample Amount10 (5 separate samples for BFE and 5 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
SBP210Synthetic Blood Penetration for Face Masks$430.00
Sample Amount32 masks are required for each pressure, 1 extra for setup; specify pressure when submitting samples (80, 120 or 160 mmHg)10 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 CodeTest DescriptionUnit Price/Turnaround Time
NRC110Sodium Chloride (NaCl)$2,740.00 per set
Sample Amount20 masks14 calendar days
NRC115Dioctyl Phthalate (DOP)$3,050.00 per set
Sample Amount20 masks14 calendar days
NRC120Inhalation and Exhalation$490.00 per set
Sample Amount3 masks10 calendar days
NRC125Valve Leak Test$490.00 per set
Sample Amount3 masks14 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) this test and 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:

1)      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).

2)      Provide a printed, signed and dated copy of the attached completed Sample Submission Form (to prevent any delays).

3)      Ensure a copy of the Purchase Order is included within the box with 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.  When you are ready to submit samples, please contact your Sales Account Manager or our Sales group Sales@nelsonlabs.com for a formalized quote or any additional questions.  Above are some sample submission instructions for your reference when you are ready to ship samples.