When answering the question of the importance of surgical masks for dentists, orthodontists, and oral surgeons it is important to know the difference and the protection offered. Surgical masks have been used since the ancient times. The earliest recorded face masks date back to 6th century BC. Persian tombs were discovered with pictures of individuals wearing cloth face covers worn over their mouths. In ancient China, scarves were worn that were made from gold threads and silk materials during the Yuan Dynasty. 

During the 14th century, the Black Death arrived in Europe. During this period, the birth of face masks was prominent and promoted. French doctor Charles de Lorme invented what was called the beak mask in the 16th century. He had glass installed in the area where the eye sockets were to increase visibility, perfumes that included camphor, spices, and mint leaves were placed in the beak section to help keep disease and other foreign particles out. The mask added along with the gloves, pants, top hat, and shawl that made up the beak suit eventually turned into a death symbol due to the spread of the plague and the death rate. During this same period, Leonardo da Vinci (the famous painter) suggested putting cloth in water and letting it soak up the water then placing it over the nose and mouth to help filter out toxins and disease. This method is still used today in guides around the world for proper fire escape safety guidelines. 

During the 19th century the mask designs took a large step forward. Robert Brown, a Scottish scientist founded the Brownian motion, which helped to prove how masks can be effective in filtering dust. The patent for the first protective mask was obtained in 1848 made by American Lewis Hassley. These masks were made for miners. The masks resembled gas masks more than surgical masks or face coverings. The patent number for the masks is 6529 and can still be found in the archives here in the United States. 

Microbiologist and chemist Louis Pasteur proved the existence of bacteria in the air in 1861. This is when people began paying closer attention to the design of the modern masks of today. 

One of the best available examples is when a French doctor constructed a surgical mask that had six separate layers of cotton gauze and affixed it to the collar of a surgical gown. This newest type of mask was created in 1899. To use the mask, all the physician had to do was turn the collar up for protection. This mask grew to become a mask that hung on the individual's ears with straps and could be freely tied and untied to be removed. Thus, the more modern mask was born.  

As there were several more outbreaks of the flu and other infectious diseases and smog with the birth of modern industry the materials used to construct masks continued to evolve to help better filter out airborne particles. 

In 2003, The SARS epidemic was noted to be the largest scale of mask use in China. Following the SARS outbreak the Chinese used large amounts of masks due to the smog in the air. In 2012, the name “PM2.5” became exceedingly popular in the public realm, and models of masks such as KN90 and N95, which can filter out fine particles, became very prevalent and extensively studied.

The Minnesota Mining and Manufacturing Co, which is known as the 3M mask has been producing these masks since 1967. Remarkably, the very idea of 3M was born from the idea of disposable bras for women. One employee suggested that a mask that was disposable could help guard employees’ lungs and noses in severe working environments such as smelting and mining. 

Understanding that adult-sized masks did not fit children correctly nor offered the right amount of protection the tech company Airmotion worked with design studio Kilo Design to invent a mask just for children. This mask is now well-known as the Woobi Play. 

What is ASTM?

One of the biggest questions when it comes to ASTM is what these letters stand for. ASTM was previously recognized as the American Society for Testing and Materials. ASTM was originally created by scientists and Pennsylvania Railroad engineers in the 1898. The main purpose was to originally prevent and address rail breaks that were afflicting the industry by brainstorming standards that would create higher quality products for the railroad. 

The American Society for Testing and Materials is now known as ASTM International. Comprising over 30,000 members including consumers, product users, creators, consultants, and academics, the STM is still headquartered in Pennsylvania. The ASTM has offices all over the globe including in Canada, Belgium, Mexico, China, and Washington DC.  

ASTM publishes and develops technical standards for numerous industries with the main goal of enhancing safety and performance over a large range of systems, materials, services, and products. ASTM standards are recognized and held up all over the globe, and each has their own number that is unique. The standards fall into different categories that include: 

  • Terminology Standard
  • Standard Classification
  • Standard Practice Guide
  • Standard Test Method
  • Standard Specification

ASTM also offers proficiency testing, inter-laboratory crosscheck programs, and technical training programs. 

In many industries, ASTM compliance is the law. For example, all toys sold in the United States must meet ASTM F-963 specifications thanks to the United States Government Consumer Product Safety Improvement Act of 2008. 

ASTM Level 3 Surgical Mask

Different surgical masks are used for different levels of protection and understanding the difference is vital for proper protection. The common definition for surgical mask is as follows. A surgical mask is disposable and loose fitting. Masks are intended to create a physical barrier between the nose, mouth, the environment for intended use. Surgical masks of today are intended for single use and to be disposed of properly.  

The Food and Drug Administration (FDA) considers surgical masks to be medical devices. All surgical masks have a classification by the American Society of Testing and Materials (ATSM). The FDA is the governing force over the marketing and sales of all masks (surgical) and sets the recommendations for manufacturers for mask protection and performance in the following areas:

  • Biocompatibility
  • Flammability
  • Bacterial Filtration Efficiency
  • Particulate Efficiency 
  • Differential Pressure 
  • Fluid Resistance

The FDA is also responsible for making sure that alternative PPE products are available in the case of worst scenarios and the safety of imported materials. Test performance data for surgical masks is required by the FDA and this includes fluid penetration resistance (ASTM F1862, 16 CFR Part 1610 Flammability, bacterial filtration efficiency (ASTM F2101), and differential pressure (MIL -M- 36954C). 

Mask Fluid Resistance Testing

  1. Fluid Resistance: Fluid resistance is the medical mask’s ability to reduce the extent of fluid that could transmit from the outer layers to the inner layer because of spray or splash. ASTM requires synthetic blood at pressure of 80, 120, or 160 mm Hg to be certified for low, medium, or high fluid resistance.  
  2. Surgical Masks Pressure Differential: Delta P is the measurement for air flow resistance of the surgical mask and the measure of breathability. Delta P uses the measurement units of mm H2)/cm2. The lower the value the more breathability the mask has. Masks must have a Delta P of less than 5.0 for high and moderate barrier masks according to ASTM standards. Delta P of less than 4.0 are required for low barrier masks. 
  3. Cytotoxic Tests and Skin Sensitivity: All surgical face masks must be testing in compliance with ISO 10993-5 10 for cytotoxic tests and skin sensitivity to be sure that no materials used in manufacturing are dangerous to the wearer. 

The ASTM Level 3 surgical mask is considered the maximum barrier protection mask available. These masks are to be used in situations that have the possibility for heavy exposure to fluids, sprays, or aerosols. 

Why ASTM Level 3 Masks are a Must Have for Dentists, Orthodontists, and Oral Surgeons

There are various types of medical masks available for sale on the market. Masks for dental care providers can vary in patterns, comfort, fit, price, and levels of protection. But are you purchasing the right masks for the procedures that are being performed daily in your practice? As dental professionals, the level of mask may not be studied and thought of on a routine basis. There are new professionals in the field that may not realize what the level indicator on the boxes of masks mean. Performing the job we love also entails keeping ourselves safe and protected at all times. The wearing of the proper level of mask also aids to ensure that we keep our patients safe. 

Level 3 masks are considered a high barrier. The procedures that are included for this type of masks are periodontal surgery, complex oral surgery, crown preparation, using an air polisher or ultrasonic polisher. 

When using ASTM Level 3 Surgical Masks it is important to change and properly discard the mask after every patient. Also, if using high aerosols, the mask should be changed every 20 minutes.

Properly wearing the medical mask should be noted. Although many individuals wear the masks, they do not wear them properly. One side of the mask is to go toward and fully cover the chin. The opposite side needs to be pulled over the nose fully. Wearing the mask correctly protects both you and the patient. 

ASTM Level 3 Mask Online

Even during this time of COVID-19 it is possible to get ASTM level 3 masks online. Of course, it is important to get the surgical masks from a reputable company and make sure the level is correct to get the protection needed. A quick internet search for “astm level 3 mask amazon” gives plenty of results for ordering the masks through reputable companies. 

ASTM Level 3 Masks Sold by:

  • Pac-Dent iMask
  • Vaxxen Labs
  • Luxury Office
  • Nelson Labs

Masks can be purchased from companies located in the United States or elsewhere. The prices will vary depending on the company and the amount of ASTM level 3 masks purchased at a time. Of course, there is the option of purchasing the surgical masks directly from the manufacturers. Most suppliers will offer discounts when products are purchased in bulk and delivered directly to the dental medical practice.

ASTM Level 3 vs n95

With the onset of COVID-19 and the shortage of personal protection equipment the WHO recommended that medical masks be worn when interacting with COVID-19n patients. The N95 respirators were being conserved for frontline workers and EMS providers. 

ASTM Level 3 masks are designed to cover the nose and mouth and have ear loops to hold the mask in place. These masks are also disposable and can be purchased in bulk. The N95 respirator mask must be fit tested to each individual user. N95 respirators are normally retested for fitting every 12 months. This tight-fitting respirator cannot provide the best protection if it does not fit properly. N95 respirators are not the same as ASTM Level 3 masks. 

Understanding the different mask levels and the protection they offer is important to all in the medical field. Having the ability to protect ourselves and our patients is something that we all need to take seriously. Currently of COVID-19 it is not just medical personnel that should be wearing face coverings. Making sure that everyone is protected is the best way to help slow the spread of the Coronavirus. 

For those who have had to close dental practices during this pandemic and are getting ready to reopen it is not easy. But the more knowledge that we are equipped with the better chances we have at putting this all behind us closer in the future. The CDC, WHO, and AMA have the latest updates and regulations on PPE and best safety precautions available. Here is a resource: https://www.ama-assn.org/press-center/press-releases/ama-launches-physician-guide-reopening-medical-practices. As regulations change, they are updated very quickly.