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Coronavirus - Face Masks - Respirators - 3D-Printed Swabs

Information For Consumers

Information For Manufacturers

Nelson Laboratories is a leading provider of microbiological and analytical lab testing. We are committed to upholding the highest standards of testing and building strong partnerships with manufacturers to improve and save lives. Nelson Laboratories does not manufacture any products sold to the general public; neither can we make claims about the overall safety and efficacy of a product. Nelson Laboratories performs specific testing to assess the performance of materials and products relative to a specification. The results provided to the manufacturer relate only to the items tested. The manufacture is responsible for making any conclusions about what the results mean to their overall batch of product and the consistency of the manufacturing process.

Can Nelson Labs Verify Report Authenticity and Product Safety/Efficacy?

It has come to our attention that some of our test reports are being modified and falsified to mislead consumers.  Please note that test reports are only authentic if provided as a complete report.  Any report with missing or modified sponsor, sample, or test information is not authentic.  If you wish to have Nelson Labs authenticate a report, please email the entire report to ReportAuthentication@nelsonlabs.com – pdf format is preferable.

Due to the large number of requests and the time required to verify against our archived records, we are only able to respond to requests from government, regulatory, and business entities.  We cannot verify individual requests.

Note:  Even if we determine that a test report is authentic, the report makes no representations and provides no guarantees or warranties about the actual condition, performance, safety, or use of the product in question.  We cannot confirm that the samples tested in this report are representative of the products that you have or will receive, or that the test sponsor has not made any changes to its manufacturing processes or materials, which would require additional testing.

Please contact the manufacturer of the product in regards to the safety and efficacy of the product in question. We also encourage you to refer to the CDC’s recommended manufacturers list of NIOSH-Approved N95 Particulate Filtering Facepiece Respirators and to review the FDA’s guidance regarding face masks.

During these unique times Nelson Labs understands the importance of providing you with fast, accurate, and high quality testing. We understand that you may have many questions regarding our testing services, which is why we’ve compiled the following information to quickly guide you through the quote process for protective barrier testing. Our new FACE MASK PRE-CONSULTATION CHECKLIST and our TESTING SPECIFICATIONS CHECKLIST are great places to start if you are new to face mask and respirator testing.  Once you have looked over the required specifications and are ready to move forward with your project, you can quickly and easily request a quote via our REQUEST A QUOTE page.  If you have questions about your project which are not answered on this page, you can ASK OUR EXPERTS for help.

FDA Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency

The US Food and Drug Administration (FDA) announced a new enforcement policy for face masks and respirators used during the COVID-19 public health emergency.  FDA is lifting requirements for certain masks and respirators to increase their availability. CLICK HERE to read more.

If you are interested in manufacturing face masks or respirators the FDA has put together THIS NEW WEB RESOURCE that helps answer your questions and provides next steps for action.

Face Mask & Respirator Testing Requirements

There are different testing requirements for face masks depending on whether you are located in the US or Europe. Download our Face Mask Testing Requirements and our Respirator Testing Requirements PDFs to assist you in determining which tests are required for your location. 

Protective Barriers Testing Services Offered

VALIDATION OF 3D-PRINTED SWABS

Widespread testing for COVID-19 is the best way to track and trace the spread of the virus.  However, there is a nationwide shortage of the nasopharyngeal (NP) swabs needed to collect samples for COVID-19 testing. These swabs are typically used for testing for influenza and other respiratory infections. The test swabs are somewhat difficult to manufacture and require design features and qualities that include a mix of stiffness, flexibility, biocompatibility, autoclavability, and the ability to capture and carry a specimen effectively.  The current supply chain shortages are serious enough that manufacturers are using 3D printing to design and manufacture swabs to fill this need as quickly and safely as possible.

There are several aspects to consider when addressing the appropriateness of a 3D-printed swab for use in the context of COVID-19 testing.  CLICK HERE to download a brochure that addresses the the following:

  • Biocompatibility
  • Suitability for sample recovery
  • Microbiological Quality
  • Functionality
  • Packaging

FREQUENTLY ASKED QUESTIONS

FAQs for Consumers

Does Nelson Labs Manufacture or Sell Face Masks and Respirators?

Nelson Laboratories does not manufacture any products sold to the general public; neither can we make claims about the overall safety and efficacy of a product. 


How do I know if A Face Mask or Respirator Will Protect Me From Coronavirus?

Please refer to the CDC’s guidelines for prevention of COVID-19 and contact the manufacturer to inquire about proper use and efficacy of a specific product.


Can You Test A Face Mask or Respirator That I’ve Purchased?

Nelson Labs does not offer consumer testing options. Due to the nature of our tests we work directly with medical device manufacturers to provide testing and validation specific to their products and needs.


How do I make a face mask from common household items or various fabrics?

Face masks are designed from specialized materials with often unique designs developed to provide a combination of performance factors which include filtration efficiency of small particles and aerosol droplets and breathability. Nelson Labs does not encourage or consult on how to make face masks.

FAQs for Manufacturers

I have the ability to make many face masks from materials used in other industries. Can Nelson Labs help me?

Nelson Labs does not consult on face mask design and creation. However, we do have significant expertise with regard to face mask and other protective barrier testing. We can execute the required performance testing on your finished product and provide the data you need to compare to the industry requirements and submit to the relevant regulatory bodies. Please contact us when you are ready to get a quote to conduct performance testing on your finished product.


Can Nelson Labs use the coronavirus disease (COVID-19) in lab testing?

Nelson Labs does not use the coronavirus disease (COVID-19) in any of our testing.  However, we do use other, laboratory safe, viruses as surrogates in our protective barrier testing for personal protective equipment (PPE).  By using surrogates, we can create worst-case challenges that safely simulate the physical characteristics of the COVID-19 virus to determine how well the PPE will function against the actual virus.

NEWS, UPDATES & EDUCATION