In recent years, the global market for medical protective equipment has shifted from demand driven by short-term pandemic surges to stable, long-term procurement by hospitals. For those of you planning to enter the medical consumables industry, future competitiveness will no longer depend solely on product pricing; it will also hinge on whether your products comply with AAMI standards and whether you possess stable, automated production capabilities. This is particularly true for advanced surgical gowns, which impose rigorous requirements regarding manufacturing processes, equipment stability, and product consistency.

In this article, we will compare surgical gowns and isolation gowns, explain the AAMI PB70 protection standards, analyze the growing trend toward fully automated production, introduce the manufacturing processes behind both products, and provide practical guidance on choosing the right automation strategy for 2026.

The core difference between surgical gowns and isolation gowns

What Is a Surgical Gown?

A surgical gown is a sterile protective garment worn by medical personnel in the operating room during surgical procedures. It belongs to the category of high-level medical protective apparel and provides bidirectional protection by helping prevent the transmission of microorganisms and bacteria between healthcare workers and patients. Surgical gowns are classified as Class II medical devices regulated by the U.S. Food and Drug Administration.

What Is an Isolation Gown? 

Isolation gowns are commonly used in non-surgical medical settings, and medical staff often wear them in wards and clinics. It belongs to basic and simple protection, mainly used to block common pollutants. In the market, isolation gowns are more inclined towards high-frequency consumption products.

Difference : Surgical Gown vs Isolation Gown 

AAMI PB70 Protection Levels: Requirements and Application Scenarios 

What is AAMI PB70 Level standard? The AAMI PB70 standard is a technical standard developed by the Association for the Advancement of Medical Instrumentation to evaluate the liquid barrier performance of medical protective apparel such as surgical gowns and isolation gowns.

Surgical gowns must meet sterile requirements and provide a higher level of fluid protection. Therefore, most surgical gowns are designed to comply with AAMI PB70 Level 3 or Level 4 standards.

In comparison, although most isolation gowns are non-sterile products, their protection levels can still range from AAMI Level 1 to Level 3 depending on the specific application and medical environment.

Why Are More and More Factories Shifting Toward Fully Automated Production?

With the continuous increase in quality and consistency requirements for medical protective apparel in European and American markets, the Association for the Advancement of Medical Instrumentation PB70 standard no longer only defines the barrier performance of products, but has also significantly influenced the manufacturing process of protective gowns.

For both isolation gowns and surgical gowns, different protection levels not only represent varying degrees of liquid barrier performance, but also imply stricter requirements for material stability, as well as for the sealing, welding, and stitching of critical garment areas during production.

As a result, traditional manual manufacturing methods are no longer sufficient to consistently meet these increasingly strict standards. This is one of the key reasons why many manufacturers are shifting toward fully automated production lines.

Automated Manufacturing Processes for Isolation Gowns and Surgical Gowns 

Compared to surgical gowns, isolation gowns are more suitable for fully automated production. The demand for isolation gowns in the market is greater and they are a continuous consumable product. For your factory, the core competitiveness of isolation clothing is no longer whether it can be produced, but gradually shifting towards：

• Whether you can maintain long-term and stable continuous production

• Whether you can reduce reliance on labor

• Whether you can ensure product consistency

• Whether you can reduce manual folding and packaging

As a result, more and more isolation gown manufacturers are adopting automated production lines.

So, what are the typical processes in an automated isolation gown production line?

1. Tension Control System

Isolation gowns are typically made from PP nonwoven fabric or other medical-grade nonwoven materials. During high-speed production, stable material tension directly affects dimensional consistency and the quality of subsequent welding processes. If material deviation, stretching, or wrinkling occurs during feeding, it can lead to misalignment in welding positions, resulting in size deviations and defective products.

Therefore, modern fully automated isolation gown production lines are usually equipped with an automatic tension control system to ensure stable and continuous operation.

2. Static Elimination System

Due to the high speed unwinding and transportation process, medical non-woven fabrics are prone to static electricity, which can cause material adsorption, deviation, or unstable feeding, thereby affecting subsequent molding and welding. In order to improve the stability of materials and reduce manual intervention in the production process, the automated production line of isolation clothing will be equipped with an electrostatic elimination system.

3. Ultrasonic Welding and Seam Forming

Ultrasonic welding is one of the core processes in fully automated isolation gown manufacturing machines. Compared with traditional manual stitching, ultrasonic welding enables material bonding without needle holes, improving both efficiency and hygiene.

The ultrasonic welding system is commonly used for:

• Body forming

• Sleeve attachment

• Tie welding

• Edge sealing

Therefore, stable ultrasonic welding quality is critical to ensuring overall product quality.

4. Cutting Process

After welding, the isolation gown is automatically shaped and cut by an automated cutting system. The cutting process determines the final product dimensions and overall garment structure.

To support high-speed continuous production, servo motor control systems are typically used to ensure high precision and stability.

5. Vacuum Conveying and Automatic Collection

After forming, the finished products are transported to the next workstation through a vacuum conveying system. This reduces manual handling, minimizes human contact, and significantly improves production efficiency.

6. Folding and Packaging

Once the product is formed, it enters the automatic folding system. The equipment automatically folds the gowns and then transfers them to the packaging system.

This process greatly reduces labor dependency while ensuring consistent packaging quality and appearance.

Manufacturing Process of Surgical Gowns 

Compared with isolation gowns, surgical gowns have a higher technical barrier. The production process involves more complex folding procedures, reinforcement patch application at critical areas, and precise welding and stitching techniques to enhance liquid barrier performance, as well as strict requirements for sterile packaging.

The sleeve cuff connection and the main body of surgical gowns are often processed using separate equipment to complete sleeve assembly and body stitching.

Finished surgical gowns must undergo the following tests:

• Hydrostatic Pressure Test: to verify liquid barrier performance

• Impact Penetration Test: to simulate blood splash exposure and evaluate resistance performance

How should we choose the right direction for automated production in 2026？

What Kind of Factories Are Suitable for Isolation Gowns?

Isolation gowns are more like fast-moving consumable products. They are suitable for factories that aim to quickly enter the medical protective apparel market, pursue high production output, operate long-term supply for hospital consumables, and reduce labor costs while improving production efficiency. They are also ideal for large-scale export orders.

If your factory already has stable orders, then investing in automated production equipment is highly suitable.

What Kind of Factories Are Suitable for Surgical Gowns?

Surgical gowns have a higher technical barrier and require more advanced manufacturing capability. Production must comply with target market regulatory requirements and typically requires certification such as International Organization for Standardization ISO 13485.

Compared with isolation gowns, surgical gowns generally offer higher profit margins.

Conclusion 

If you are currently planning an automation upgrade for your factory, you are welcome to contact us for consultation. Our engineering team can provide customized production line solutions tailored to your needs.

Hengyao Automation has long been focused on the medical nonwoven automation industry, providing customized automation solutions for manufacturers. We help factories improve production efficiency, reduce labor dependency, and enhance product consistency.

Our fully automated isolation gown production machines are designed to meet all your isolation gown manufacturing requirements.

FAQ

What AAMI level is required for surgical gowns?

In standard operating room environments, surgical gowns are typically required to meet AAMI Level 3 or Level 4 protection. Level 4 protective gowns must pass the ASTM F1671 viral penetration test, which requires extremely high seam integrity and liquid barrier performance.

What should I consider before investing in a gown production line?

You should consider the required AAMI protection levels for their target export markets, production capacity and local labor availability, regulatory compliance requirements, and future scalability for automation upgrades.

What materials are commonly used in isolation gown production?

Isolation gowns are typically made from PP (polypropylene) nonwoven fabric.

Can isolation gowns be fully automated?

Yes. Hengyao Automation has developed fully automated isolation gown production lines that cover the entire process from raw material feeding to final product packaging.

Can isolation gowns and surgical gowns be produced using the same equipment? 

For example, regarding our company's equipment, our isolation gowns can achieve fully automated production and packaging, while surgical gowns can only be produced using semi-automatic manufacturing machines