Medical Gowns intended for use in health care settings include surgical gowns, isolation gowns, surgical isolation gowns, non-surgical gowns, procedural gowns, and operating room gowns.
They are used to protect the wearer from the spread of disease-causing microorganisms if the wearer comes in contact with potentially infectious liquid or solid material. They may also be used to help prevent the wearer from transferring microorganisms that could harm vulnerable patients, such as those with compromised immune systems.
The FDA recognizes the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70.
This standard establishes a system of classification for protective apparel and drapes used in healthcare facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance.
A surgical gown is regulated by the FDA as a Class II medical device that requires a Premarket Notification 510(k) .
Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a Premarket Notification 510(k).
Non-surgical gowns are Class I devices intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination. These products are exempt from Premarket Notification 510(k).
In the FDA review known as Premarket Notification 510(k) clearance, the manufacturers have to show they meet specific criteria for performance, labeling, and intended use, to demonstrate substantial equivalence.
One way substantial equivalence may be demonstrated, in part, is by conforming to consensus standards for barrier performance and resistance to tears and snags. Voluntary consensus standards may also be used to demonstrate sterility (when applicable), biocompatibility, fluid resistance, and flammability.
Manufacturers must validate the methods used to test conformance to standards and support each product with appropriate performance test data.
To identify FDA-cleared products, search the Premarket Notification 510(k) database using the product codes for gowns (FYA, FYB, FYC).
The applicable product codes are:
Surgical gowns (FYA)
Isolation gowns and surgical apparel accessories (FYC, LYU, OEA)
Surgical suits (FXO)
Companies (establishments) that are involved in the production and distribution of medical devices intended for use in the United States, are required to register and list their products with the U.S. Food and Drug Administration, then renew their registration between October 1 and December 31, each year.
A foreign company or registrant must provide the name, address, and phone number of the foreign registrant’s U.S. Agent, such as ITB HOLDINGS LLC.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Establishment Identification (FEI) number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
The FDA recognizes the DUNS Number as an acceptable Unique Facility Identifier (UFI) for the purpose of registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.
If you are a part of a group purchasing organization (GPO), or a manufacturer in China, India, Mexico, Europe, you may want to contact ITB HOLDINGS LLC.
