FDA 510 K Submission - Surgical Gown

A surgical Gown is a type of protective clothing intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Surgical gowns are usually made of a non-woven fabric that is lightweight and breathable but also provides a barrier to liquids and bacteria. They come in different levels of protection depending on the procedure being performed, with higher levels of protection being necessary for more invasive surgeries.

Surgical gowns typically have long sleeves and a closed front to ensure full coverage of the wearer's body. They may also have elastic cuffs to prevent the sleeves from riding up and ties at the back or side to secure the gown in place.

It's important for surgical gowns to be properly donned and removed to prevent contamination. Healthcare professionals are trained to follow strict protocols for donning and doffing their personal protective equipment, including surgical gowns.

Some different types of surgical gowns are:

  1. Disposable Surgical Gowns: These gowns are made of non-woven materials and are designed for single use only. They are typically lightweight and breathable, providing comfort and flexibility during procedures.

  2. Reusable Surgical Gowns: These gowns are made of more durable materials such as polyester or cotton, and they can be laundered and reused multiple times. They are typically more substantial and offer better protection against fluids and contaminants.

  3. Impervious Surgical Gowns: These gowns are designed to be completely fluid-resistant and provide excellent protection against blood, bodily fluids, and other potentially infectious materials.

  4. Non-Impervious Surgical Gowns: These gowns are designed to be less fluid-resistant and are typically used for less invasive procedures or procedures with minimal fluid exposure.

  5. Sterile Surgical Gowns: These gowns are designed for use in sterile environments such as operating rooms, and they are specially treated to be free of bacteria and other contaminants.

  6. Non-Sterile Surgical Gowns: These gowns are designed for use in non-sterile environments such as clinics or outpatient settings. They are typically less expensive than sterile gowns and do not require the same level of processing and handling.

FDA Classification for Medical and Surgical Gowns

Regulation Number

Gown Code

Gown Class

Gown Type

878.4040

FYA

Class 2

Surgical Gown

878.4040

FYB

Class 2
510(K) Exempt

Patient Gown

878.4040

FYC

Class 2

Surgical Isolation Gown

878.4040

QPC

Class 2

Non-Sterile, Non-Isolation Gown

878.4040

QSO

Class 2

Medical Gowns With Chemotherapy Labeling Claims

880.6265

FME

Class 1
510(K) Exempt

Examination Gown

878.4040

OEA

Class 1
510(K) Exempt

Non-Surgical Isolation Gown

LMG Provides assistance to surgical gown manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements.

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

  • Prepare surgical gown 510k notification
  • Submission of surgical gown 510k notification
  • FDA Agent service for 510k submission
  • Guidance in test requirements
  • Register your establishment with FDA
  • List your surgical gown and medical gown with FDA.

Test Requirements for a surgical gown for US FDA 510K Submission

US FDA 510K Submission Requirements

FDA 510K Consultant