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Surgical Face Masks and General-Use Masks – ASTM F2100 & EN 14683

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.

Nelson Labs offers a comprehensive set of tests for surgical face masks and general-use medical masks. These tests are essential to ensuring performance properties are validated to support marketing label claims and to classify these mask types.

For CE marking submissions, additional tests may be required depending on label claims.

Summary of face mask tests for ASTM2100:

Additional tests to consider for surgical face masks:

For masks that require NIOSH respirator certification (e.g., N95), please see the Respirator Pre-Submission test page.

Download our Face Mask Testing Requirements to assist you in determining which test is required for your location.

Applicable Standards

  • ASTM 2100
  • EN 14683
  • ISO 10993

Testing Locations

  • Salt Lake City, UT, USA

Learn more about our locations and their certifications.

Study Outline

See individual test pages linked above for test specific study outlines.

If you have additional questions about Surgical Face and General-Use Masks testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.