U.S. Surgical Gowns Level AAMI 3 Market Size, Share & Trends Analysis By Usability (Disposable Gowns, Reusable Gowns), By Gown Type (Fabric Reinforced, Non-fabric Reinforced), By Surgery, By End Use, By Region, And Segment Forecasts, 2025 - 2033

Market Size & Trends

The U.S. surgical gowns Level AAMI 3 market is driven primarily by the increasing demand for infection prevention in healthcare settings, the rising number of arthroscopic orthopedic, endoscopic urological, and mastectomy procedures in the U.S. For instance, according to the Knee Pain Centers of America article published in February 2025, about 700,000 knee arthroscopies are performed yearly, resulting in costs exceeding USD 3.0 billion annually. Further, according to the University of Florida Health, kidney stone disease impacts roughly 1 in every 500 people in the U.S. annually. Throughout their lifetime, about 1 in 8 men-most commonly between ages 40 and 60, and one in sixteen women-most commonly between ages 20 and 50-will experience this condition. In addition, according to Brigham and Women's Hospital, each year, more than 100,000 women undergo some form of mastectomy. Therefore, the increase in kidney stone diseases, breast cancer cases, and the corresponding rise in mastectomy procedures are driving market growth.

AAMI Level 3 surgical gowns offer moderate barrier protection, making them suitable for procedures with moderate fluid exposure, which is common in hospitals and surgical centers. The rising number of surgeries, particularly outpatient procedures, contributes to the growing need for reliable protective apparel. The increasing adoption of minimally invasive procedures, such as laparoscopic surgeries, further propels market growth. For instance, according to an article by North Kansas City Hospital & Meritas Health, approximately 15 million laparoscopic procedures are performed annually in the U.S., making it one of the most frequently conducted surgeries and offering benefits for numerous medical conditions.

Additionally, the growing aging U.S. population contributes to a higher incidence of chronic diseases requiring surgical intervention. Hospitals and surgical centers increasingly seek cost-effective, high-performance gowns, spurring demand for reusable and eco-friendly options. Market consolidation and strategic partnerships among manufacturers and distributors help streamline supply chains and improve availability. Lastly, federal and state funding for hospital preparedness and infection control programs supports sustained investment in high-quality surgical gowns like those meeting AAMI Level 3 standards. In the U.S., founded in 2002, the Administration for Strategic Preparedness & Response, ASPR’s Hospital Preparedness Program (HPP), aims to ready the healthcare delivery system to address community needs, ensure equitable access to care, and save lives during disasters and emergencies. By Section 319C-2 of the Public Health Service (PHS) Act, the Administration for Strategic Preparedness and Response (ASPR) allocates Hospital Preparedness Program (HPP) cooperative agreement funding to recipients based on a legislatively mandated formula. Furthermore, the CDC's Public Health Emergency Preparedness (PHEP) Cooperative Agreement funds 50 states, four cities, and 8 U.S. territories and freely associated states.

Regulatory emphasis on healthcare worker and patient safety has led to stricter compliance requirements, boosting the adoption of certified gowns. For instance, according to Cardinal Health, protective apparel, including surgical gowns, is regulated by standards and testing protocols that all manufacturers must meet. These standards are established by the Association for the Advancement of Medical Instrumentation (AAMI). Specifically, ANSI/AAMI PB70:2012 defines a classification system (Levels 1 through 4) for protective apparel used in healthcare settings, including surgical gowns. This classification is based on liquid barrier performance assessed through standardized testing methods. The U.S. Food and Drug Administration (FDA) has adopted ANSI/AAMI PB70:2012 as the mandatory standard that all surgical gown manufacturers must follow.

Technological advancements in fabric materials such as SMS (Spunbond-Meltblown-Spunbond) and multilayer laminates enhance protection and comfort, increasing market competitiveness.

In addition, the growing prevalence of cancer is also expected to boost demand during the forecast period. For instance, according to the American Cancer Society report, in the U.S. in 2025, approximately 316,950 new cases of invasive breast cancer are expected to be diagnosed in women, along with about 2,800 cases in men. Additionally, an estimated 59,080 cases of ductal carcinoma in situ (DCIS) will be diagnosed in women. The year is projected to see around 42,680 breast cancer-related deaths, with 42,170 occurring in women and 510 in men.

Estimated Number of New Cases for Selected Cancers in the U.S., 2025 

Estimated Number of New Cancer Cases by State, U.S., 2025

Source: American Cancer Society

Market Concentration & Characteristics

The surgical gowns level AAMI 3 industry in the U.S. is moderately concentrated. Key players such as Cardinal Health, Henry Schein, Inc., Boston Scientific Corporation, Owens & Minor, and Medline Industries, LP, drive innovation. Market growth is fueled by rising demand for minimally invasive surgeries and increasing awareness about infection prevention in healthcare settings. The industry features strong R&D investments, strategic partnerships, and geographic expansions to enhance market presence. In addition, increasing awareness and favorable reimbursement policies support adoption. While barriers to entry include high development costs and regulatory hurdles, innovation and clinical efficacy continue to shape the competitive landscape. The surgical gown level AAMI 3 industry has witnessed significant advancements.

The U.S. surgical gown level AAMI 3 industry is witnessing significant innovation, primarily driven by the need for enhanced protection materials. Level 3 gowns are designed to provide a high liquid barrier resistance, making them suitable for procedures with moderate to high exposure risks. Manufacturers are increasingly integrating advanced textile technologies, such as fluid-resistant and breathable fabrics, to balance protection with comfort. Innovations also include the development of gowns with improved durability, antimicrobial properties, and environmentally sustainable materials.

Implementing regulations based on ANSI/AAMI PB70:2012 Level 3 standards has significantly impacted the U.S. surgical gown market. As Level 3 classification indicates a high level of liquid barrier protection suitable for moderate to high-risk procedures, manufacturers must meet stringent testing and quality assurance protocols to ensure compliance. This has led to increased research and development efforts to produce gowns that balance protection, comfort, and cost-effectiveness.

The market has seen moderate mergers and acquisitions, driven by the need for expanded product portfolios and technological capabilities. Companies are strategically aligning to enhance distribution networks and enter new regional markets. These consolidations support innovation while maintaining competitive pricing and compliance with evolving healthcare regulations.

The U.S. surgical gown Level AAMI 3 industry is moderately fragmented, with numerous regional players competing based on product innovation, pricing, and regulatory compliance. While a few established companies hold significant market share, emerging players continue to enter with niche offerings.

Regional expansion in the U.S. surgical gowns Level AAMI 3 market is driven by strategic investments and collaborations to address healthcare challenges. For instance, in October 2023, in partnership with the MoneyGram Haas F1 Team, based in Kannapolis, the Starlight Children’s Foundation launched a unique Starlight Hospital Gown featuring the VF-23 theme at St. David’s Children’s Hospital in Austin, Texas.

Usability Insights

The disposable gowns segment dominated the market in 2024 due to several key factors. Primarily, disposable gowns offer unparalleled convenience and efficiency, eliminating the need for laundering and reducing the risk of cross-contamination between patients and healthcare workers. Their single-use nature ensures high hygiene and compliance with strict infection control standards mandated by regulations like ANSI/AAMI PB70:2012 Level 3. Additionally, disposable gowns are cost-effective for healthcare facilities because they minimize labor and maintenance costs associated with reusable gowns. The increasing focus on infection prevention, especially amid ongoing concerns about healthcare-associated infections (HAIs), has further driven the preference for disposable options. Moreover, advancements in high-performance materials have enhanced the protective qualities of disposable gowns, aligning with regulatory standards while providing comfort and flexibility.

The reusable gowns segment is expected to grow significantly in the U.S. surgical gowns Level AAMI 3 market over the forecast period. The reusable gown segment is driven by increasing awareness of environmental sustainability and cost savings over the long term, as healthcare facilities seek eco-friendly and economically advantageous options. Innovations in durable, high-barrier fabrics that meet stringent Level 3 standards have also contributed to their rising popularity. For instance, Standard Textile Co., Inc. is one of the leading companies that offer reusable AAMI PB70 Level 3 surgical gowns. This gown is compatible with steam sterilization and has patented ComPel fabric that repels fluid/liquid while allowing moisture vapor to pass through.

Gown Type Insights

The fabric reinforced segment held the largest share in 2024. Fabric reinforcement involves incorporating additional layers or specialized materials into the gown fabric, significantly enhancing durability and liquid barrier protection, which are essential for high-risk surgical procedures classified under Landards. This reinforcement provides a higher level of safety and reliability, making these gowns more suitable for procedures with increased exposure to fluids and contaminants. Additionally, fabric-reinforced gowns offer improved structural integrity, reducing the risk of tears or breaches during use, which is critical in maintaining infection control. The growing demand for protective apparel that maximizes safety without compromising comfort has further fueled the adoption of fabric-reinforced gowns.

Due to several key factors, the non-fabric reinforced segment is anticipated to experience significant growth in 2024 in the U.S. surgical gowns Level AAMI 3 market. Firstly, advancements in material technology have led to the development of innovative non-fabric reinforced fabrics that offer enhanced liquid barrier protection while maintaining flexibility and comfort for healthcare workers. These materials often incorporate specialized coatings or layered constructions that provide superior resistance against fluids and microbes, aligning with the high-performance requirements of Level 3 gowns. Additionally, manufacturers are shifting towards non-fabric reinforced options because they are more cost-effective, easier to produce, and environmentally friendly than traditional fabric-reinforced gowns. The rising demand for lightweight, disposable, and high-performance protective apparel-especially in the context of ongoing concerns about infection control-further fuels this growth.

Surgery Insights

The general surgery segment held the largest share in 2024, driven by the increasing volume and complexity of surgical procedures across healthcare facilities. The demand for high-level protective gowns in general surgery reflects the need for reliable liquid barrier performance to safeguard healthcare workers against bodily fluids, blood, and other infectious materials during invasive procedures. Advances in gown material technology and adherence to strict regulatory standards, such as ANSI/AAMI PB70:2012 Level 3, have reinforced the preference for durable and compliant products in this segment. Additionally, the rise in surgical procedures due to an aging population and the prevalence of chronic diseases has contributed to sustained growth. Hospitals and surgical centers prioritize safety and compliance, fueling the adoption of Level 3 gowns in general surgery.

The endoscopic surgery segment is projected to be the fastest growing in the U.S. Surgical Gowns Level AAMI 3 market from 2025 to 2033 due to several compelling factors such as increasing adoption of minimally invasive procedures, like laparoscopy and endoscopy, is driving demand for specialized protective apparel that can withstand the unique requirements of these surgeries. Endoscopic surgeries often involve longer durations and require higher levels of barrier protection to prevent contamination, making Level 3 gowns essential. The growing number of hysterectomy procedures is fueling the growth of the endoscopic surgeries segment. For instance, according to an article from Brigham and Women’s Hospital, approximately 500,000 laparoscopic hysterectomies are performed annually in the U.S. The majority of these procedures are conducted to treat benign conditions, including fibroids, abnormal uterine bleeding, and pelvic organ prolapse.

End Use Insights

The operating room segment dominated the U.S. surgical gowns level AAMI 3 in 2024 due to several factors such as high level of liquid barrier protection of level 3 surgical gowns, making them essential for a wide range of surgical procedures that involve significant exposure to bodily fluids and blood, thereby elevating their demand in the operating room setting. According to Medline Industries, LP news, as a reliable provider of medical supplies, Medline Industries’ surgical gowns are used in over 40% of U.S. operating rooms, facilitating more than 20 million procedures annually.

Regulatory standards and hospital protocols prioritize using high-protection gowns to ensure patient and healthcare worker safety, especially during complex or high-risk surgeries. Additionally, the increasing volume of surgical procedures, driven by advancements in medical technology and an aging population with complex health needs, has further boosted demand for robust protective apparel in operating rooms. The focus on infection control and compliance with strict safety standards has also encouraged healthcare facilities to prefer Level 3 gowns, reinforcing their dominance in this segment.

The emergency room segment is expected to grow significantly in the U.S. Surgical Gowns Level AAMI 3 market. Several factors contribute to this rapid growth. First, the increasing prevalence of urgent and emergency medical cases-such as accidents, trauma, and infectious disease outbreaks-necessitates using high-level protective apparel to ensure the safety of healthcare workers and patients. Second, hospitals and emergency facilities are prioritized to upgrade their protective gear to meet stringent safety standards, including Level 3 requirements, to prevent cross-contamination and infection transmission. Additionally, advancements in emergency medicine and a focus on infection control protocols drive the demand for reliable, high-performance surgical gowns.

Key U.S. Surgical Gowns Level AAMI 3 Company Insights

Cardinal Health, Owens & Minor, Medline Industries, LP, Henry Schein, Inc., Boston Scientific Corporation, Standard Textile Co., Inc., Encompass Group, LLC, and Dynarex Corporation are some of the major players in the U.S. surgical gowns Level AAMI 3 market. Companies are expanding their portfolios of level 3 surgical gowns to gain a competitive advantage in the coming years.

Recent Developments

• In April 2023, Taromed announced the successful completion of its 2.1 version of a fully automated production line for isolation and surgical gowns in the U.S. This milestone marks a significant achievement in the company’s ongoing commitment to delivering exceptional medical gowns to its customers.

• In November 2023, Medica 2023 concluded, celebrating a significant milestone for Taromed as it showcased its latest technology for manufacturing Isolation and surgical gowns via a fully automated production line.

• In October 2023, in collaboration with the MoneyGram Haas F1 Team, based in Kannapolis, the Starlight Children’s Foundation launched a unique Starlight Hospital Gown featuring the VF-23 theme at St. David’s Children’s Hospital in Austin, Texas.

• In April 2024, Henry Schein Medical, the healthcare division of Henry Schein, Inc., announced its upcoming participation in the Ambulatory Surgery Center Association (ASCA) 2024 Conference and Expo. During the event, the company's Ambulatory Surgery Center (ASC) Division showcased an expanded capital equipment portfolio and comprehensive planning services tailored to new ASC constructions and expansions. Team Schein also highlighted its streamlined supply chain and distribution solutions designed to support independent and hospital-owned ambulatory surgery centers.

KoL Responses

• On Medline and 3M collaboration to standardize surgical warming gowns (2024)- Jim Abrams said, “We aligned the two brands to say, ‘Let’s focus No. 1 on what is best for the patient. It was groundbreaking for the industry to say that. But 3M leadership was as committed to this strategic initiative as we were.” Abrams admits that the strategy is slightly non-traditional. But once the two companies committed to putting patients first, team members began to see the benefits of having a strategic, capable partner who could deliver innovative solutions for their customers.” - Jim Abrams, Chief Operating Officer of Medline Industries.

U.S. Surgical Gowns Level AAMI 3 Market Report Scope

U.S. Surgical Gowns Level AAMI 3 Market Report Segmentation

This report forecasts revenue growth at the country level and provides an analysis on the latest industry trends in each of the sub-segments from 2021 to 2033. For the purpose of this study, Grand View Research has segmented the U.S. surgical gowns level AAMI 3 market report on the basis of usability gown type, surgery, and end use:

• Usability Outlook (Revenue, USD Million, 2021 - 2033)

  • Disposable Gowns

  • Reusable Gowns

• Gown Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Fabric Reinforced

  • Non-fabric Reinforced

• Surgery Outlook (Revenue, USD Million, 2021 - 2033)

  • General Surgery

  • Orthopedic Surgery

  • Endoscopic Surgery

  • Gynecological Surgery

  • Mastectomy

  • Others

• End Use Outlook (Revenue, USD Million, 2021 - 2033)

  • Operating Room

  • Intensive Care Unit (ICU)

  • Emergency Room

  • Others