Mask Standards Explained: Disposable 3 Ply

While the COVID-19 pandemic drove our economy to the brink of collapse, technological innovation and supply chain perseverance has allowed our nation to stay afloat and reinvent itself. Before this global pandemic, PPE was reserved for hospital facilities and research laboratories, but in this new world, every sector of the economy can only function with implementation of the proper safety equipment and protective gear. Accordingly, many of you are new to purchasing PPE, and could use assistance in making decisions about which products are right for you.

At PRS, our team has a strong technical background in the hard sciences and medical space, and we are here to help guide you through some of the misconceptions in the marketplace.  

What are Disposable 3 Ply Masks?

Disposable masks have the ability to relieve the transfer of saliva, respiratory particles or even blood between individuals. These masks have multiple layers of non woven fabric materials, fused together, and designed for single use. The material components will degrade with use, as each layer is exposed to moisture, biologic materials, and heat.

What is ASTM?

Two international organizations are responsible for the common terminology in the disposable 3Ply marketplace: European Committee for Standardization (CEN) & American Society for Testing and Materials (ASTM). In recent years, the CEN has showed effort to align the standards for medical face masks (EN 14683) with its peer in the US (ATM F2100 or F2101). Founded in Philadelphia, with employees stationed across the United States (New York, California, Delaware & Florida), PRS will prioritize the terms developed by ASTM International for product analysis.

The priority metrics used in evaluating Disposable 3 Ply masks are (i) Bacterial Filtration Efficiency, % ; (ii) Differential Pressure, mm H2O/cm2 Pa/cm2 ; (iii) Sub-micron Particulate Filtration Efficiency at 0.1 Micron, % ; (iv) Splash Resistance / Synthetic Blood Resistance, mmHg Pass Result ; (v) Flame Spread. These metrics are exhibited in the table below:

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What do the different ASTM levels mean?

While many refer to ASTM F2100 disposable masks as a “Civilian Grade” mask, the technical details reveal a more intricate usage. World experts at Halyard Health, describe their ASTM F2100-11 Level 1 disposable masks as competent for procedural and even surgical usage, maintaining both breathability and comfort for the user.

The ASTM F2100 Level 2 mask is commonly referred to as a “Medical Grade” mask, often designed with either soft-elastic ear loops, to comfortably fit around the ears of the user, however we also offer 3Ply masks, manufactured with tie-back strings. Tie-back strings allow for a custom fit for the wearer. Leading experts market these products as medical or surgical masks.

The ASTM F2100 Level 3 mask is designed to meet the highest standards for disposable procedure/surgical masks.

Sources:

https://www.nelsonlabs.com/en14683-harmonizes-bacterial-filtration-efficiency-and-differential-pressure-with-astm-f2100/

https://www.cdc.gov/coronavirus/2019-ncov/hcp/non-us-settings/emergency-considerations-ppe.html

https://www.halyardhealth.com/media/188242/c1485_astm-masks-full-line-sell-sheet.pdf

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