What Is Surgical Apparel and Why Are Definitions Matter?

According to the report by Next Move Strategy Consulting, the global Surgical Apparel Market size is predicted to reach USD 5.26 billion by 2030 with a CAGR of 6.6% from 2025-2030.

Surgical apparel refers to gowns, masks and other protective garments worn by operating room personnel to prevent transfer of microorganisms, body fluids and particulate matter during procedures. Clear definitions ensure that products marketed as “surgical” meet consistent performance and safety requirements.

Download Your Free Sample Here: https://www.nextmsc.com/surgical-apparel-market-hc2895/request-sample

Key Points

• Surgical gowns are Class II medical devices requiring a 510(k) premarket notification under FDA regulations.
• Ambiguity in terminology—for example, between “surgical gowns,” “isolation gowns” and “scrub suits”—can lead to inappropriate use and variable protection.
• The FDA’s June 2015 guidance aims to clarify which gowns fall under different device classifications and the data needed to support liquid‑barrier claims.

Conclusive Statement
Establishing precise definitions for types of surgical apparel is essential to ensure that each garment delivers the intended level of protection, and that manufacturers submit the correct regulatory filings before market launch.

What Are the Waste Challenges Associated with Surgical Apparel?

According to Supply Chain Dive, Operating rooms can generate up to 35 % of all hospital waste, with gowns and related packaging contributing a large share. Because most isolation and surgical gowns are single‑use and supplied in sterile packs, disposal volumes can be substantial.

Sources of Waste

• Disposable gowns and drapes that cannot be laundered once opened
• Blue sterilization wrap (polypropylene) used for instrument packs
• Packaging materials such as plastic trays, wrapping and over‑packs

Conclusive Statement
Without targeted interventions—such as reusable gowns or optimized pack contents—surgical apparel waste will continue to strain hospital sustainability goals and increase operational costs.

How Are Regulatory Standards Governing Surgical Apparel Evolving?

The FDA guidance of June 2015 reinforced descriptive standards and performance testing requirements for gowns intended for health care use.

Regulatory Highlights

• Classification: Surgical gowns and masks remain Class II (special controls), while other surgical apparel (e.g., scrub suits, caps) are Class I.
• Barrier Claims: Manufacturers must perform standardized liquid barrier testing (e.g., ANSI/AAMI PB70 levels) to substantiate protection claims.
• Labeling: Garments must be clearly labeled with intended use, barrier level and single‑use or reusable status.

Conclusive Statement
Strengthened guidance helps align industry terminology and establishes clear pathways for manufacturers to demonstrate compliance, ultimately enhancing safety and reducing regulatory confusion.

What Strategies Are Hospitals Implementing to Reduce Surgical Apparel Waste?

According to Supply Chain Dive, Health systems are finding both low‑tech and high‑tech solutions to curb the environmental footprint of surgical apparel.

Waste‑Reduction Approaches

• Reusable Gowns
• Institutions like UCLA Medical Center switched to launderable isolation gowns, diverting nearly 300 tons of landfill waste and saving over US $1.1 million in three years.
• Pack Optimization
• Reformulating standard surgical packs to include only frequently used items can prevent hundreds of dollars’ worth of unused supplies per procedure.
• Advanced Sterilization
• CDC‑approved decontamination methods for certain single‑use items allow safe reuse, reducing overall procurement volumes.
• Recycling Partnerships
• Non‑profit programs (e.g., Partners for World Health) collect unopened gowns and supplies for redistribution to underserved regions, giving material a “second life”.

Conclusive Statement
By combining reusable apparel, smart pack design, decontamination protocols and redistribution programs, hospitals can significantly lower waste without compromising patient safety.

Next Steps: Actionable Takeaways

1. Audit Your Surgery Packs
• Review items included in standard packs; eliminate rarely used components to reduce discards.
2. Evaluate Reusable Apparel
• Pilot washable isolation gowns and compare lifecycle cost and waste reduction to disposables.
3. Engage Supply Chain Teams
• Collaborate with procurement to set sustainability criteria and track garment performance data.
4. Partner with Recycling Initiatives
• Identify local or national programs that accept unopened gowns and packaging for redistribution.
5. Stay Informed on Regulatory Updates
• Monitor FDA guidance for any new standards on barrier testing and device classification.

By defining surgical apparel clearly, embracing waste‑reduction strategies and adhering to strengthened regulatory guidance, health care facilities can protect both patient safety and the planet—while potentially realising significant cost savings.