What Should You Know About ASTM Standards For Medical-Grade Masks?

19 September 2022
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Purchasing wholesale medical-grade masks for use in your organization is much different from purchasing the simpler, cloth-style consumer-grade masks that have become common over the last few years. Medical-grade masks function as legitimate personal protective equipment (PPE) and must meet specific industry standards and government regulations.

The American Society for Testing and Materials (ASTM) provides one of the most well-known and recognized standards for evaluating and testing medical-grade masks. The FDA also bases its approval on this standard. If you're making a bulk PPE purchase, it's critical to understand how ASTM standards impact the level of protection for the masks you're buying.

Face Coverings, Medical Masks, and Respirators – Understanding the Difference

Before diving into how ASTM standards apply to medical-grade masks, it's critical to understand how various protective products on the market vary. Cloth masks or non-medical grade face coverings typically do not meet official standards. These products generally cannot make specific claims and rarely offer similar protection to medical-grade products.

On the other hand, medical-grade masks require FDA approval and typically meet one of three ASTM levels described below. These products are appropriate for medical settings and provide protection and source control. Finally, respirators are a separate class of products that require NIOSH (National Institute for Occupational Safety and Health) approval and can provide protection against various threats.

Medical Mask ASTM Ratings – What You Need to Know

If you're comparing medical-grade products, you'll usually see them with one of three ASTM levels. These levels may be given numerically or listed as low (1), medium (2), or high (3). Each level corresponds to specific standards for bacterial filtration, particulate filtration, fluid resistance, breathability, and flame resistance.

While higher-grade masks provide better protection, the differences can be subtle. For example, Level 2 and Level 3 masks have identical requirements for filtration, breathability, and flame resistance, with the primary difference being that Level 3 masks offer greater fluid protection. On the other hand, Level 1 masks offer greater breathability at the expense of lesser filtration and fluid resistance.

The correct masks for your setting will depend largely on your application and the risks in your usage environment. Level 1 masks provide basic source control and help protect the wearer from incidental contact with hazardous fluids. However, these masks are not certified for resistance against higher-pressure fluid contact, such as might be present in trauma situations.

Ultimately, it's essential to remember that medical-grade masks must carry an ASTM rating and use approved testing methods. By choosing a mask that meets these standards and understanding which level corresponds to your particular environment, you will be able to choose a mask that offers suitable and reliable protection.

Reach out to a medical grade face mask wholesaler near you to learn more.