Medical Face Masks and ASTM F2100

by | Jun 19, 2023 | ASTM, Compliance, FDA, Medical Devices, Safety

The American Society for Testing and Materials (ASTM) is an organization that publishes production and testing standards for a variety of differing industries. Many of the Food and Drug Administration (FDA) requirements for bringing a medical device to market rely on these standards for testing and evaluation, referred to as recognized consensus standards. ASTM F2100, which was most recently revised in 2023, contains performance standards for the materials used in medical face masks [1]. These types of standards documents contain information for a variety of styles/types of face masks and the testing requirements to meet higher classification standards (Level 1 barrier, Level 2 barrier, or Level 3 barrier).

The standard testing methods of ASTM F2100 include bacterial filtration efficiency (BFE), breathing resistance / differential pressure, sub-micron particulate filtration, resistance to penetration by synthetic blood, and flammability [1]. Specifically, capture of sub-micron particles and resistance to penetration by synthetic blood are tested at three varying velocities (minimum, middle velocity, maximum velocity) for the classification of the level of barrier the mask falls under (Level 1 barrier, Level 2 barrier, or Level 3 barrier). However, these two test procedures are defined in ASTM F3502 [2] and ASTM F1862 [3], respectively. Each of these methods are independently defined by other ASTM/ISO/CFR requirements and testing procedures. Proper application of this standard is crucial for FDA compliance and being able to properly market your medical face mask.

If you need help understanding the regulatory testing requirements for any type of medical device that you want to get on the market while maintaining FDA compliance, the team of experts at EMMA International can help! Contact us today at or by calling 248-987-4497.

[1] ASTM. (2023, March 09). Standard Specification for Performance of Materials Used in Medical Face Masks. American Society for Testing and Materials.

[2] ASTM. (2022, July 20). Standard Specification for Barrier Face Coverings. American Society for Testing and Materials. [3] ASTM. (2017, June 28). Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity). American Society for Testing and Materials.

Chris Powell

Chris Powell

Chris is a highly skilled research scientist with a focus on bioinformatics, ecological modeling, big data analysis, genomics/proteomics, phylogenomics, and molecular clock analyses. He holds a PhD in Biology from Oakland University, specializing in Bioinformatics, Genomics, and Phylogenetics. Additionally, he has a Master of Science degree in Biology, where he worked in ecology and specialized in ecological data analyses using various techniques, such as timeseries analyses, statistical inference, survival modeling, and stochastic processes modeling. Chris has a strong background in Linux, computer hardware, mathematical modeling, and programming languages, including HTML, CSS, JavaScript, Perl, and R Programming Language. He brings 5+ years of teaching experience and over 12 years of research experience to EMMA International, showcasing a keen interest in data sciences that utilize big data to answer pressing questions and further our understanding of the world.

More Resources

Ready to learn more about working with us?

Pin It on Pinterest

Share This