Understanding Medical Gowns and Classifications

Medical gowns are a type of personal protective equipment (PPE) that are used to provide a barrier between individuals and potential contagions. A gown can be used to protect the wearer as much as it can be used to protect other people from the wearer. They’re often one part of a larger PPE strategy which can include masks and gloves.

Medical gowns are also referred to as isolation gowns, surgical gowns, surgical isolation gowns, non-surgical gowns, procedural gowns, and operating room gowns. These terms do not all refer to the same item as there are separate classifications of medical gowns.

Medical Gown Classifications

The medical field is highly regulated to offer the best and safest practices as a standard. The American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) has created a classification system for medical gowns and other protective apparel that the FDA has accepted and adopted.

The levels of protection listed below refer to qualities of the fabric and not the shape or the areas of focus for protection.

Level 1: Minimal Risk

Gowns that fall into the level 1 category are not sterile and offer a minimal degree of protection. They’re typically used in patient visits or check-ups in all sorts of medical offices. They do offer a slight barrier, but large quantities of liquids can penetrate level 1 gowns. Their main purpose is to prevent the wearer’s clothes from transferring anything to another person or the environment. There are both washable and disposable versions of this gown.

These gowns may also be used in non-medical situations like food services or cosmetology businesses.

Level 2: Low Risk

Level 2 gowns are a step up and offer a bit more protection, but they are still not a sterile gown. If you’re comparing level 1 and level 2, they look similar, but you will feel that a level 2 is denser, offering better liquid protection and they stand up to washes fairly well. Even though they’re better at repelling liquids, they’re still used in situations where fluid exposure is controlled and not likely – like a blood draw situation or lab work.

These gowns are also used in the field of cosmetology and food services. They do a good job of protecting the wearer’s clothing from spills and splatters.

Level 3: Moderate Risk

Level 3 gowns up the protection and are good for a moderate risk situation. Because the level of risk in many situations is unknown at the outset, health care professionals often opt for this gown level to give them more protection “just in case.” They are used in many ICUs, ERs, and situations where there are blood draws or other bodily fluids may be present. These gowns offer more fluid resistance. Level 3 gowns can be sterile or non-sterile.

Level 3 gowns are typically not used outside of the healthcare industry. They’re not necessary in food and cosmetology situations.

Level 4: High Risk

This is the highest level of protection offered by a medical garment and it’s designed for situations where infectious diseases are suspected, where bodily fluids are common, and where pathogen resistance is needed.

Level 4 gowns have the highest level of fluid and microbial barrier available. They are used during surgical procedures and offer pathogen resistance, protection against non-airborne diseases, and are an effective barrier against large amounts of fluids for an extended period of time.

Level 4 gowns are not necessary in food and cosmetology situations and are almost solely found in medical situations.

Medical Coveralls and Suits

Medical gowns aren’t the only garment made to protect the body in a medical situation. A medical coverall or suit might be used to add an even higher level of protection from transfer, whether from wearer or to wearer, and additional coverage.

Medical coveralls are not automatically “more protective” than gowns as they come in levels 2, 3, and 4. A level 2 coverall will offer some protection to more areas, but a level 4 gown will still provide a higher level of protection in the most significant regions of the body. There are both disposable and reusable versions of medical coveralls.

Because these suits offer full-body coverage, they are often used in other environments like industry, food and beverage processing, painting, law enforcement, hazardous waste clean-up, etc.

Coverage Areas

In addition to having different levels of material, FDA classifies surgical gowns by the areas of concentrated protection.

Surgical Gowns

Surgical gowns are regulated by the FDA as a Class II medical device. They’re designed to be worn by health care professionals during surgical procedures and offer protection to both the wearer and the patient. Large critical zones of protection from the transfer of microorganisms, bodily fluids, and particulates are identified as the regions from the wrist or cuff to above the elbow and the region from the top of the shoulders to the knees in the front. All surgical gowns must be sterile and labeled as such.

Surgical Isolation Gowns

When there is a medium or high risk of contamination, larger zones of coverage are necessary. Surgical isolation gowns are regulated by the FDA as a Class II medical device and the entire gown except bindings, cuffs, and hems are considered critical zones of protection. This means they have the highest level of liquid protection throughout.

Non-Surgical Isolation Gown

The FDA categorizes this gown as a Class I device, offering all of the protection of the surgical isolation gown but they’re not to be used in a surgical situation or in a high-risk event. These gowns offer maximum protection from fluids and are used in low to minimal risk patient isolation cases.

Non-Sterile Non-Isolation Gown

These gowns provide moderate or high barrier protection in situations where there are no isolation concerns, and a sterile garment is not required. They fall into the FDA Class II medical device classification.

Non-Surgical Non-Isolation Gown

These gowns offer the same level of low to minimal protection throughout without pre-specified critical zones. They’re never used in surgical situations.

Where to Buy Medical Gowns

If you’re looking to stock-up on medical gowns, ROMI Medical has a complete line of medical gowns and coveralls for all situations. ROMI Medical is a woman-owned business focusing on medical and PPE supplies. If you want to learn more about our options and pricing, you can request a custom quote for isolation gowns.

ROMI Medical is a part of the New York Microscope Company, if you’re looking for additional medical equipment, such as high-quality microscopes, we can help! You can find a large selection of microscopes here at the New York Microscope Company.