Surgical Gown VS Isolation Gown? What are the differences?
To help you choose the right gown, we take you through all the fundamentals and the key things in selecting the best one.
As the COVID-19 outbreak continues, the use of isolation gowns is now becoming popular among the public. They are part of personal protective equipment (PPE). During this time of the pandemic, the demand for gowns from the public is also increasing. Because the rise of the virus spread is becoming more threatening. It gives us more reasons to find simple alternatives to fight the virus. Isolation gowns can significantly help people to protect themselves.
It is essential to know how to choose the best isolation gown level for protection. It can be confusing to choose the right quality isolation gown from a multitude of manufacturers.
Types of Isolation Gowns
Isolation Gowns (non-surgical isolation gowns)
An isolation gown protects front-line PPE from fluid penetration and infectious droplets. The disposable gowns offer to prevent microorganisms from being transmitted to those with weak immune systems.
Surgical Gown
Surgical Gowns are specialized medical garments worn by surgeons and scrub nurses during operative procedures. They are almost always supplied as sterile products, packaged individually to maintain a sterile field the O.
The defining feature of a surgical gown is its Critical Zones . According to FDA Class II medical device standards, the critical zone for a surgical gown includes the front of the body (from chest to knees) and the sleesal on the uffyleion the unyeeal tos suffy the sleesal the tests because they are most likely to come into direct contact with blood and bodily fluids. The back of a surgical gown is often non-protective to allow for breathability, as the surgeon does not turn theirback on the patient.
Surgical Gowns vs Isolation Gowns:
To help procurement teams quickly identify the regulatory and functional differences, refer to this specification table:
| Feature | Surgical Gown | Isolation Gown | Non-Surgical Isolation Gown |
|---|---|---|---|
| Primary Use | Sterile Surgical Procedures (OR) | Medium-High Risk / Trauma | Routine Care / Visitors / Low Risk |
| FDA Regulation | Class II (Requires 510k) | Class II (Requires 510k) | Class I (Exempt) |
| Critical Zones | Front (Chest to Knees) & Sleeves | Entire Gown (including back) | Varies (Usually entire gown) |
| Sterility | Usually Sterile | Sterile or Non-Sterile | Usually Non-Sterile |
| Back Protection | Often Non-Protective (Breathable) | Protective (Full Coverage) | Protective |
What are the Reusable Isolation Gowns?
Reusable isolation gowns are made from durable, washable fabrics and are designed to be used multiple times. They provide the same level of protection as disposable gowns, but at a fraction of the cost. Reusable gowns are an excellent choice for healthcare facilities looking to reduce their environmental impact and save money.
What is the Critical Zone for Surgical Gown?
The barrier requirements for the design and construction of surgical gowns, other protective apparel are based on the anticipated location and degree of liquid contact, given the expected conditions of use. The critical zones include those areas where direct contact with blood, body fluids, and other potentially infectious materials, although areas outside of the critical zones can inadvertently be sprayed or splashed as well.
Critical Protection Zones for Surgical Gowns
- The entire front of the gown (areas A, B, and C), including the seam and other components, is required to have a barrier performance of at least level 1.
- The critical zone compromises at least areas A and B.
- The back of the surgical gown (area D) may be non-protective.
Example of a surgical gown
- Critical zone — front
- Critical zone — sleeve
- Front
- Back
Source: Critical Zones for Surgical Gowns. (2021, January 13). [Photograph].
Critical Zones for Surgical Isolation Gowns and Non-Surgical Gowns
- The entire gown (areas A, B, and C), including seams but excluding cuff, hems, and bindings, is required to meet at least the minimum level 1 of barrier performance.
- When there is a high risk of infection and a need for more critical zones, surgical isolation gowns can be used.
Example of a surgical Isolation gown and non-surgical gown
- Critical zone — front
- Critical zone — sleeve
- Critical zone — back
“Surgical Gowns and Surgical Isolation Gowns are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.”
“Non-Surgical Gowns are Class I medical devices (exempt from premarket review)”
Isolation gown level
The protection level refers to the minimum set of security measures that must be implemented by organizations in order to protect their information and systems. These standards are typically set by government or industry bodies, and organizations must ensure that they comply with these standards in order to avoid penalties or other consequences.
What are the AAMI Levels of Protection?
The AAMI levels of protection are a system used to classify medical devices according to their level of invasiveness. There are four levels, with Level I being the least invasive and Level IV being the most invasive. Devices that are classified as Level I have little or no potential for harm to the patient, while those classified as Level IV have a high potential for harm.
AAMI Level Selection Guide
To ensure your facility is compliant, use this guide to match the procedure to the correct protection level:
| AAMI Level | Fluid Risk Level | Common Procedures | Test Requirement |
|---|---|---|---|
| Level 1 | Minimal | Basic Care, Visitor Cover, Standard Isolation | Impact Penetration (Water Spray) |
| Level 2 | Low | Blood Draw , Suturing, ICU, Pathology Lab | Impact + Hydrostatic Pressure (Rising Water) |
| Level 3 | Moderate | Arterial Blood Draw , IV Insertion, ER Trauma | Higher Hydrostatic Pressure limits |
| Level 4 | High | Long Surgery , Pathogen Resistance Needed | Viral Penetration (ASTM F1671) |
Testing Standards: Hydrostatic Pressure & Viral Penetration
To achieve these AAMI ratings, gowns must undergo rigorous testing standards:
- AATCC 42 (Impact Penetration): Measures how well a fabric resists liquid spray. (Required for Levels 1-3).
- AATCC 127 (Hydrostatic Pressure): Measures the fabric’s resistance to water under pressure. This is a critical test for Hydrostatic Pressure , ensuring the gown won’t leak even when a surgeon leans against wet.
- ASTM F1671 (Viral Penetration): This is the “gold standard” test for Level 4 gowns. It uses a surrogate virus (bacteriophage Phi-X174) to ensure that not even microscopic viruses can pass through the erial.
3 Things to Evaluate When Choosing an Isolation Gown
The Centers for Disease Control (CDC) suggests that you consider three things when choosing gowns for healthcare settings.
Purpose
- Who will be wearing the gown?
- In what setting will they be working?
- What are the possible types of risks?
Answers to those questions determine what type of isolation gowns you need.
Materials – What are isolation gowns made of?
- Disposable isolation gowns are made from polyethylene or polypropylene.
- Reusable isolation gowns are made from cotton or synthetic materials, such as polyester or poly-cotton blend. They can also be latex-free.
Synthetic materials generally do a better job of blocking fluids and are preferred over cotton when it comes to COVID-19 prevention.
How to Choose: Infection Control & Risk Assessment for Facilities
The Centers for Disease Control (CDC) suggests a comprehensive risk assessment when selecting Medical Gowns . It’s not just about buying PPE; it’s about matching the gown to the specific Infection Control needs of your facility.
Quick Risk Assessment Checklist for Procurement
Before placing an order, run through this checklist to determine the necessary protection level:
Procedure Type: Is it invasive (Surgery) or routine (Check-up)?
Fluid Volume: Do you expect heavy splashing, soaking, or just mist?
Duration: Will the procedure take 30 minutes or 4 hours? (Longer procedures often require higher barrier protection).
Sterility: Does the procedure require a sterile field? (Yes = Surgical Gown).
Risk Level Assessment
The risk level of the environment determines the AAMI level required.
For example, in a low-risk environment (like a standard Blood Draw ), the medical professional needs an AAMI Level 2 gown to prevent splash contamination. Conversely, for invasive surgeries with high fluid expexposure, onlyn Level 44a conf .
How to Put on and Remove an Isolation Gown?
The ease or difficulty with which a gown is put on and removed may affect its effectiveness and the potential for contamination, especially during the doffing of a contaminated gown.
Put on
- Select the appropriate type and size
- The opening is in the back
- Secure at neck and waist
- If a gown is too small, use two gowns for better protection
- Put on the first gown with the opening in front and the second gown over the first with the opening in the back.
Take off
- Unfasten ties
- Peel gown away from neck and shoulder
- Turn contaminated outside toward the inside
- Fold or roll into a bundle (Only the “clean” part of the gown should be visible)
- Discard
Hand hygiene is an important part of the job for Health Care Providers. Hand hygiene can be achieved by using an alcohol-based hand sanitizer containing 60-95% alcohol, or by washing your hands with soap and warm water for at most 20 seconds. Hands that are visibly stained should be washed with soap and water before returning to the alcohol-based hand sanitizer.
Clean vs. Sterile Medical Gowns
There are two main types of medical gowns: clean and sterile.
- Clean gowns are typically used during less invasive procedures
- Sterile gowns are reserved for more serious or invasive procedures.
Sterile gowns are designed to protect the wearer from exposure to blood, body fluids, and other infectious materials. They are usually made of a disposable material like paper or plastic and are often blue or green in color.
Clean gowns, on the other hand, are not necessarily disposable and can be made of a variety of materials including cotton or polyester. While they offer some protection from exposure to blood and body fluids, they are not as effective as sterile gowns in preventing the spread of infection.
How to Choose the Right Isolation Gown to Prevent COVID-19
According to the CDC’s COVID-19 resources, selecting the correct level of isolation gown depends on the protection needed for the circumstances.
Patients
For patients with suspected or confirmed cases of COVID-19, please use non-sterile disposable patient isolation gowns, which are used for routine patient care in healthcare settings.
Medical Professionals
For medical professionals engaging in activities where the risk of bodily fluid exposure is low or minimal, gowns that claim minimal or low-risk levels of barrier protection (ANSI/AAMI PB70 Level 1 or Level 2) can be used.
For situations where medium to high-risk levels of contamination and need for a large critical zone, isolation gowns that claim moderate to high barrier protection (ANSI/AAMI PB70 Level 3 or Level 4) can be used.
Conclusion
Companies might advertise different product names when they are selling isolation gowns (e.g., patient gown, nursing gown, procedural gown, non-surgical gown, etc.) It is important to consider the function and intended use of the product, as well as what level of protection it offers. You will be able to choose the right isolation gown by looking at the description and packaging.
The Product label is more important than the product name.
