Surgical Gowns Level AAMI 3 Market Report Scope & Overview:

The Surgical Gowns Level AAMI 3 Market size was valued at USD 750.60 million in 2024 and is expected to reach USD 1746.33 million by 2032, growing at a CAGR of 11.14% over the forecast period of 2025-2032. 

The Surgical Gowns Level AAMI 3 Market growth trend heavily depends on enhanced infection prevention regulations that have been put in place globally, following the COVID-19 pandemic. Healthcare facilities, including hospitals, have placed far greater emphasis on eliminating healthcare-associated infections (HAIs) and safeguarding the health of patients alongside the medical personnel. This has led to a universal movement to use higher-grade PPE, with AAMI Level 3 gowns becoming the minimum requirement for many surgical and procedural areas. These gowns protect from moderate fluid and microbial exposure, which is required in operating rooms, emergency rooms, and ICUs. Accrediting bodies and health certification organizations have intensified audits and compliance criteria, which has increased the need for certified gowns. In turn, these developments with stringent infection control measures have cemented AAMI Level 3 gowns as a hallmark in healthcare institutions, thus driving sustained market growth.

For instance, according to the WHO, Surgical care has been an essential component of health care worldwide for over a century. As the incidences of traumatic injuries, cancers, and cardiovascular disease continue to rise, the impact of surgical intervention on public health systems will continue to grow. Surgery is often the only therapy that can alleviate disabilities and reduce the risk of death from common conditions. Every year, many millions of people undergo surgical treatment, and surgical interventions account for an estimated 13% of the world’s total disability-adjusted life years (DALYs).

The U.S. Surgical Gowns Level AAMI 3 Market was valued at USD 244.70 million in 2024 and is expected to reach USD 561.62 million by 2032, growing at a CAGR of 10.96% during 2025-2032.  

The U.S. leads the Surgical Gowns Level AAMI 3 Market share. Cardinal Health, 3M, Medline, and Halyard Health are among the leading U.S manufacturers of surgical gowns, which guarantee robust domestic production, a responsive supply chain, and easy access to AAMI-certified products. The adoption of disposable surgical apparel at the U.S. hospitals significantly outpaces adoption elsewhere due to larger PPE budgets coupled with heightened risk aversion towards infections. Hospitals’ spending on healthcare is projected to exceed USD 4.7 trillion in 2024, which indicates that they will continue investing in elaborate protective equipment for an indefinite period of time. Close to seamless compliance tracking alongside gown usage checks made possible through automation continues to be advanced in healthcare software and procurement systems.

For instance, on 9 Oct 2024, the rise in the number of surgical procedures significantly contributes to market demand. The World Health Organization (WHO) estimates that around 313 million surgeries are performed worldwide each year. This expanding volume of surgical procedures correlates directly with increased usage of surgical gowns and drapes. A significant factor is the aging population, and according to the United Nations, by 2050, there will be 2 billion people aged 60 or over, which results in higher incidences of age-related conditions necessitating surgery.

Market Dynamics: 

Drivers

• Growing Volume of Surgeries Globally is Significantly Driving the Surgical Gowns Level AAMI 3 Market Growth

The key factor contributing to the AAMI Level 3 surgical gowns market is the volume of surgical procedures being done on a global scale. The increase in population, coupled with the higher incidence of chronic diseases, including cardiovascular disease, cancer, diabetes, and even obesity, has further intensified the requirement for surgeries. Along with these conditions, there is also an increase in trauma cases, orthopedic surgeries, trauma surgeries, and elective procedures, which greatly enhance surgical activity in both developed and developing countries.

For instance, it was predicted that over 330 million surgeries would be performed by the year 2024, which is an increase from the previously recorded estimate of approximately 200 million annual surgeries between 2018 and April 2020 (mostly due to COVID).

A significant number of surgeries performed are categorized under moderate risk and require the use of AAMI level three gowns, which provide a reasonable shield against fluid penetration. This includes hernia repairs, joint replacements, hysterectomies, mastectomies, and other similar procedures where exposure to blood or fluids does not require exceedingly thick but modest protection suffices.

• Adoption of Smart Procurement & Tracking Systems is the Key Driver of the Surgical Gowns Level AAMI 3 Market Growth

The use of smart procurement systems and inventory control management technologies in hospitals is the most effective driver for the growth of AAMI Level 3 surgical gowns. To improve efficiency, compliance, and safety within the facility, automated systems that control PPE, including surgical gowns are being adopted. Automated systems documented usage rates proving efficient in polynomial forecasting, along with automatic reordering based on consumption trends, greatly assist healthcare facilities. Consistent availability of AAMI Level 3 gowns is especially important during high-risk surgeries. It also reduces wastage, overstocking, and understocking, which were persistent issues before digitization came into play.

Restraints:

• Challenges with Reusable Gown Sterilization is Restraining the Surgical Gowns Level AAMI 3 Market Growth

Although biodegradable AAMI Level 3 reusable surgical gowns have had good environmental and economic aspects for a long time, their utilization brings along only troubles and issues that are related to the processes of cleaning, sterilization, and quality assurance. After each use, these gowns have to undergo decontamination processes that are as strict as possible to keep the fluid-resistant and microbial barrier properties. This, in turn, leads to the necessity of having modern sterilization devices, and several qualified personnel who can conduct proper training sessions and carry out rigorous quality inspection, which is often missing in many healthcare facilities, especially in developing countries or small rural hospitals. If the gowns are not sterilized properly or kept in good condition, they may lose the protection they offer, thereby, infection among patients and healthcare workers is highly likely.

Segmentation Analysis:

By Gown Type 

Fabric Reinforced is the dominant segment in the global Surgical Gowns Level AAMI 3 Market, with a 69.22% market share in 2024. Owing to its excellent barrier protection, strength, and comfort. Nonwoven material with reinforced zones ensures great resistance to fluid and bacteria penetration—ideal for moderate risk surgical settings. Their breathability and robust properties provide the clinician with safety and comfort during extended use. Demand is bolstered by rising surgical volumes, increasing infection control standards, and growing recognition of the need to protect health care workers. Moreover, hospitals are choosing fabric-reinforced gowns due to optimum safety and utility balance, especially in settings where gowns have to be worn longer without affecting movement and protection, thereby supporting the continued growth in this segment.

What makes fabric-reinforced gowns different from regular ones is the existence of reinforced panels, which are normally placed on the chest, sleeves, and front torso, the areas where the highest amount of fluid is released during surgery. These panels are intended to stop strike-through (the liquid penetration through the gown), thus being the patient and surgical staff the ones that can be free from cross-contamination and infection.

By Surgery

In 2024, the General Surgery segment dominated the Surgical Gowns Level AAMI 3 Market with a 30.22% market share. Owing to the large number of operations performed in the world, in a need of a solid barrier of fluid. PURPLE Level 3 Non-Sterile Gown by HALYARD. These low-linting gowns are made of a high-quality construction that can be worn with confidence in a variety of situations. Demand is increased by growing hospital admissions, an expanding elderly population that requires surgery, and the development of surgical techniques. Furthermore, increasing infection control practices and growing awareness of healthcare-associated infections (HAIs) drive the adoption of AAMI Level 3 gowns. Hospitals and surgical facilities give these gowns top priority to keep them safe and within their regulations during surgery.

The Endoscopic Surgery is the fastest-growing segment in the Surgical Gowns Level AAMI 3 Market analysis, with a CAGR of 11.92%. Because minimally invasive operations have become popular all over the world. The former two surgical procedures are minimally invasive surgeries, but there is a moderate risk of exposure to body fluid; thus, protection is required. AAMI Level 3 Surgical gowns are designed to meet the complex and strenuous demands of today's surgical procedures that require precision and support for simultaneous retraction. This is attributed to the development of endoscopy technology along with patient preference toward minimally invasive procedures, thereby shorter recovery times and lower risk of infection. Further driving growth in this category is the increasing volume of outpatient surgeries and the strict safety protocols adopted by hospitals.

By Usability

Disposable Gowns held a dominant Surgical Gowns Level AAMI 3 Market share of 80.52% of the global Surgical Gowns Level AAMI industry in 2024. Owing to ease of use, infection control advantages, and high levels of hospital favourability. These disposable gowns provide reliable protection whilst reducing the risk of cross-contamination and negating the need for laundry, sterilisation, or repair, and remove the need for other services to hold in stock a range of gown types. Burden of hospital-acquired infections (HAIs), rapid growth in the number of surgeries performed, and prevalence of hygiene protocols are some of the factors propelling demand. Furthermore, the disposable gowns consistently provide high quality and protection, and also the improvement in healthcare standards. The COVID-19 pandemic also hastened the transition to disposable protective gear, cementing multiyear demand from hospitals, ambulatory surgery centers, and clinics for greater safety and efficiency.

Reusable gowns are the fastest growing segment in the Surgical Gowns Level AAMI 3 Market due to environmental concerns and cost savings in the long run. Hospitals are increasingly going green, and reusable gowns can cut down on medical waste substantially. With innovations in fabric technology, these have been engineered to offer superior comfort, durability, fluid-resistance, and almost 5 times the fluid impact of AAMI level 3. They are higher cost in the beginning, but when you take into account REUSE over and over again and not having to launder, they become cost-efficient. Various government programs to encourage environment-friendly healthcare practices and the increasing need for high-performance and sustainable personal protective apparel are the key factors that are driving the demand for reusable surgical gowns.

By End-User

The Operating Room (OR) segment has the largest share of the AAMI Level 3 surgical gowns market as in the Operating Room (OR), keeping a sterile environment is of utmost importance. If contamination takes place and sterility is lost during surgery, hospital-acquired infections (HAIs) may occur that are not only harmful to the patient but also very costly for care systems. Hence, all measures are taken to ensure that ORs are strictly under the control and become the most infection-protected. Green Hospital, AAMI 3 gowns typically play a major role in the fulfillment of these hygiene requirements. AAMI Level 3 gowns are particularly designed for keeping healthcare providers safe from moderate fluid exposure, e.g., blood, saline, or other bodily fluids, which are frequently encountered during surgeries. They are also effective in blocking the invasion of viruses and thus limit the chance of the surgical staff and the patients getting infected.}

The Intensive Care Unit (ICU) is emerging as the fastest-growing segment in the AAMI Level 3 surgical gowns market. It is crucial to keep high-level infection control over the high-risk environment. ICU patients are extremely fragile beings that must be watched closely and manipulated often in a way that brings medical personnel into contact with bodily fluids. Ideal for ICU use, AAMI Level 3 gowns ensure comprehensive protection. Growing ICU admissions led by an ageing population, long-term diseases, and infections, including post-pandemic readiness, continue to drive demand. Believe it or not, strict guidelines in hospitals and an emphasis on healthcare-associated infections (HAIs) only add more traction behind the use of protective gowns.

Regional Analysis:

In 2024, the North American region holds the largest Surgical Gowns Level AAMI 3 Market share of 32.60%. North America, especially the U.S., is at the top of the food chain within the AAMI Level 3 surgical gowns market due to the staggering number of surgeries and up-to-date healthcare infrastructure. The U.S. presents a vast repertoire of surgical operations per annum, approximately 50 million cases, which come from various branches including general, orthopedic, gynecological, and cardiovascular surgeries, most of which make moderate fluid exposure a case for the use of AAMI Level 3 gowns. The area is replete with hospitals, ambulatory surgical centers, trauma units, and intensive care units, all adhering to rigorous infection control protocols, which are more than capable of handling complex and high-load procedures continuously, consequently leading to the demand for protective surgical wear being always constant. 

Europe holds a significant share in the Surgical Gowns Level AAMI 3 Market due to its well-established healthcare infrastructure, strict infection control regulations, and the widespread adoption of high-standard surgical protocols across member countries. One of the main reasons for the top position of Europe in the AAMI level 3 surgical gowns market is the extensive medical emergency fabrics and personal protective equipment (PPE) centres in the region. The availability of these facilities has enabled countries, such as Germany, Sweden, and France to have the best medical healthcare product companies including Mölnlycke Health Care (Sweden), Paul Hartmann AG (Germany), and Medline Europe.

These industrial units have the ability and are known for producing surgical gowns, drapes, and PPE of AAMI and EN13795 (European equivalent) standards, which are accepted internationally. The existence of these facilities in Europe solidifies the local supply chain and the speedy delivery, hence cutting down the need for overseas imports. This local capability not only guarantees the medical sector a quick response to needs and efficient control of inventory but also saves on freight costs.

The Asia-Pacific (APAC) region is experiencing the fastest growth in the Surgical Gowns Level AAMI 3 Market due to a fast-growing number of hospital surgeries and health services, and a rise in attention given to preventive measures concerning infections. Governments in countries including India, China, Indonesia, and Vietnam have rapidly implemented hospital projects driven by grants and an increased amount of health care funding. All of this has led to the situation in which there is a large growth in surgery, and safe-surgery masked Level 3 is mostly used in general, orthopedic, and other minimally invasive surgeries. The surge of COVID-19 has ignited more stringent infection controls in the region, which in turn, facilitated the transition of hospitals to move from regular isolation gowns to certified surgical gowns used by both patients and staff for protection.

Besides, the presence of several robust medical textile producers in the area, especially in China, India, and Bangladesh, not only ensures the possibility of a significant number of low-cost gowns being produced but also opens up the possibility of these gowns being available domestically and to the markets in the neighborhood. The first cause of the growth is the attractiveness of low-cost treatments that are internationally standardized, thus highly PPE-demanding centers, such as Thailand, Malaysia, and India. Additionally, in the case that the hospitals are up-to-date with the latest equipment, they mostly offer painless and quick treatment, thereby providing the most recent services needed by the customer. Eventually, the conglomerate's reasons put the Asia-Pacific region in the driver’s seat concerning the AAMI Level 3 sector development

The Middle East & Africa have a smaller share in the surgical gowns level AAMI 3 industruy, primarily due to the low healthcare infrastructure, the lower surgical volumes, and the inconsistent adoption of international PPE standards in many countries across the region, which are the major factors. In some parts of Sub-Saharan Africa, and the Rhodes of the Middle East, hospitals are not fully equipped for advanced surgical operations, and they are mostly committed to offering basic health care, which in turn results in the non-availability of high-grade surgical gowns including the AAMI Level 3. On top of that, there are restrictions on the budget in public healthcare systems, the importation of medical supplies, and the situation that there is no adequate stock of PPE.

The surgical gowns level AAMI 3 market has always been growing steadily in Latin America, owing to the dual increasing awareness of infection control measures and growing number of surgical procedures, with the slow development of healthcare infrastructure supporting this balance. There has been increased demand for certified protective apparel among communities in Brazil, Mexico, Argentina, and Chile have been setting up more public and private hospitals, and also investing in operating rooms and critical care units. Although the faster-growing Asia Pacific trumps Latin America in pace, international safety-level standards and AAMI are picking up steadily, mostly in urban hospitals and private hospitals. Post-COVID reforms and international collaborations have also contributed to better preparation for PPE and higher-grade surgical gowns. However, issues related to procurement, owing to a big population suffering from economic disparity in the remote areas.           

Key Players:

The surgical gowns level AAMI 3 companies include Medline Industries,LP, Cardinal Health, Inc.,3M Company, Halyard Health, Kimberly-Clark Corporation, DuPont de Nemours, Inc., Stryker Corporation, Molnlycke Health Care AB.,Berner International GmbH, and Priontex.

Recent Developments:

• In March 2025, TDSC.com, powered by Henry Schein, announced a new affiliate partnership with the Pennsylvania Dental Association (PDA). This collaboration aims to expand access to dental supplies for PDA members through TDSC.com’s online marketplace, offering competitive pricing and streamlined procurement solutions tailored for dental professionals. This collaboration enhances the accessibility of Henry Schein’s product portfolio, potentially increasing the adoption of Level 1-3 surgical gowns in dental practices.

• Halyard Health, Inc., a leading global medical technology company, divested its Surgical & Infection Prevention (S&IP) business, including its Indian subsidiary, to Owens & Minor, Inc. for USD 710 million. The divestiture allowed Halyard to sharpen its focus on its core business in the medical devices segment while Owens & Minor gained a foothold in the global healthcare supplies market.