Surgical Gown Classification
A surgical gown is a medical device.
Regulatory Classification
Surgical gowns are classified as medical devices based on their intended purpose and regulatory framework 1. The French standard EN 13795 specifically defines operating theatre attire, including surgical gowns, as devices "meant to show and having shown its effectiveness in reducing contamination of the operating wound by skin flakes containing infectious agents" 1.
Functional Purpose as a Medical Device
Surgical gowns serve a dual protective barrier function that qualifies them as medical devices:
- Patient protection: They prevent transmission of microorganisms from healthcare workers to the surgical site, thereby reducing surgical site infection risk 1
- Healthcare worker protection: They create a barrier against blood-borne pathogens (HIV, hepatitis B and C viruses) and other infectious materials from patients 2, 3, 4
Distinction from Other Product Categories
The evidence clearly differentiates surgical gowns from the other options:
- Not a medicinal product: Surgical gowns do not contain pharmaceutical substances and are not administered for therapeutic purposes 1
- Not a cosmetic product: They have no cosmetic or aesthetic application on the human body 1
- Not a biocidal product: While they may incorporate antimicrobial treatments (such as TiO₂ nanoparticles), their primary function is as a physical barrier device rather than a biocidal agent 2
Performance Standards
Medical device classification is further supported by standardized testing requirements that surgical gowns must meet 5:
- ASTM 1671 viral penetration test for barrier efficacy 2
- Impact penetration (splash) testing 5
- Synthetic blood resistance testing 5
- Viral resistance testing 5
These performance standards are characteristic of medical device regulation rather than other product categories.