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U.S. Food and Drug Administration

Assessing Fit Factor and Breathability of Pediatric Facemasks

Catalog of Regulatory Science Tools to Help Assess New Medical Devices 

This regulatory science tool is a laboratory method for measuring fit-factor of pediatric facemasks. 

Technical Description

This regulatory science tool is a laboratory based test method used to evaluate the fit factor and breathability of pediatric facemasks. This tool provides a detailed methodology for creating and using pediatric manikin headforms for fit and breathability testing. The process involves 3D printing specific pediatric headforms, applying a skin-mimicking silicone layer, and using a fit-testing instrument with an aerosol generator to quantify mask fit. The tool also outlines how to measure breathing resistance using pressure transducers at various flow rates to simulate different activity levels.

Intended Purpose 

This tool is intended to be used for testing pediatric facemasks and is applicable to devices for pediatric users from 4 to 12 years old. The tool provides a laboratory-based method to quantify the fit factor of pediatric facemasks without using human subjects.    

Testing

Testing has been conducted as part of verification of the test method as outlined in the supporting documentation1: fit factor and breathability were evaluated for a set of FDA-cleared pediatric facemasks by donning them on to manikins in the age group of 5-, 8- and 11-year-old pediatric head forms. 

Limitations

  • This tool uses static manikin headforms, which cannot simulate the effects of dynamic facial movements (e.g., talking, grimacing, head turning) or real-world use on mask fit.
  • The fit measured on a standardized headform may not be representative of the fit for all individuals in an age group, as real-world facial dimensions and features vary significantly.
  • Performance characteristics such as biocompatibility, flammability, and particle filtration efficiency are outside the scope of this tool.

Supporting Documentation

The basis for this tool can be found in the publication:

1. Hasani, A, Ibarra B., Snodderly K., Rottach D., Qian, B., Porter D., Guha, S. A Retrospective characterization of pediatric facemasks marketed in the United States and implications for future designs. Plos One. Volume 19, Issue 9, Pages e0307879. https://doi.org/10.1371/journal.pone.0307879

Further instructions are provided in the accompanying User Manual.

Contact

Tool Reference