What’s a Medical Mask? Why is It Different from a Procedural Mask?

Medical Mask Definition

All “medical masks” will carry a classification from the American Society of Testing and Materials (ATSM). Medical masks by definition, must be validated at a minimum of ASTM Level 1. Masks intended for medical purposes are considered medical devices and are regulated by the FDA.

ASTM Testing

ASTM rated masks require third party performance testing. Results must meet regulatory requirements and comply with industry standards.

Medical Masks Filtration Requirements

In general, medical masks are almost always three ply construction.

ASTM Level 1 requires a minimum 95% filtration rate. The design is often a minimum of a latex free 3 ply material, fitted nose band, and pleated fabric.

ASTM Level 2 and ASTM Level 3 masks have additional requirements for liquid and particle production. Level 2 and Level 3 filtration performance must meet or exceed 98% capture of particles 0.1 micron or larger.

ASTM Level 2 protection is adequate for industries and professions when exposure to blood and/or bodily fluids is not a risk.

ASTM 3 surgical masks provide significant protection against fluid penetration for front line workers, lab technicians, and emergency responders.

Virtually all surgical masks have soft ties instead of ear loop designs. Ties and headbands provide a more snug fit which reduces leaks and gaps along the sides of the mask.

Continue to: ASTM Level 3 Surgical Masks

Medical Mask ISO Standards

Medical face masks must be tested additionally to international standard (ISO 10993-5:2009) for skin sensitivity and cytotoxic tests to ensure that no materials are harmful to the wearer. Tests are conducted on materials used in construction of the mask which come in contact with the user’s skin. For example, ASTM 1 level masks are latex free to avoid allergic reactions.

Continue to: What are ASTM Level 1 Performance Requirements?

If a mask manufacturer does not provide an ASTM certification for breathability, fluid resistance, or flame spread — as well as appropriate bacterial and filtration efficacy — a product should not be considered fit for medical purposes.

Continue to: What are the Benefits of 3 Ply Procedural Masks vs Cloth Alternatives?

Procedural Masks Specifications

CleanPro® 3 ply masks are not considered medical masks, as they have not been evaluated as such. However, they do meet ASTM Level 2 requirements for bacterial filtration efficacy (BFE). Non-medical procedural masks are designed for general populations or non-procedural activities. Studies show that procedural masks are largely effectively in reducing the spread of respiratory droplets.

Procedural masks meet the criteria of ASTM particle efficiency and bacterial filtration, but have not been evaluated for ASTM flame, fluid, and breathability.

Here are the specifications: 

Production Automation Corporation (PAC — that’s us) is available for direct consultation and price quotes for bulk purchases. Find masks, pricing, and other PPE supplies at the PAC online store. (www.gotopac.com) In stock items are shipped from one of three PAC locations across the United States.

How Have Face Masks Changed Over Time? A Brief History of Face Coverings

Masks were not always made from advanced textiles and multilayer construction. What makes these materials so meaningful when manufacturing PPE equipment, and how has mask technology changed over time?

Where Can I Buy FDA Approved KN95 Masks?

When you buy face masks from PAC you’ll have the benefit of masks shipped from USA warehouses, in-stock availability, and bulk pricing.

What’s a Medical Mask? Why is It Different from a Procedural Mask?

Medical masks by definition, must be validated at a minimum of ASTM Level 1.

What are the Standards for ASTM Face Mask Testing?

This post will help you understand the context, performance criteria, and minimum requirements of ASTM levels in various medical masks and their respective uses fields.

Surgical Medical Masks ASTM Level 3 Requirements

This post will help you understand meaningful differences between various face mask evaluation methods and best-case use. Understanding the most common mask materials and expected performance metrics helps buyers better decide which mask is most appropriate for associated risk, cost, and wellbeing.

ASTM F2299M Medical Face Mask Test Method – Filtration Efficacy Testing

The F2299M filtration efficacy test compares particle counts before a test media meets a filter apparatus (upstream) and then measures again after (downstream) the test media passes through the material.