Your Quick Guide to the FDA’s PPE Gown Requirements

Over the last few months, PPE shortages have prompted American manufacturers from all industries to pivot their operations and produce this critical equipment. As global supply chains broke down, many chose to source and manufacture PPE gowns domestically. If you’re producing PPE gowns here in the United States—or considering joining the American Made PPE movement—use this quick guide to get an overview of the process.

(Looking for a more in-depth guide? Visit our Resources page or contact our experts.)

PPE Gown Classes

Gowns are organized into Class I, Class II and Class III, The higher the class, the more stringent the regulations for manufacturing them. Class I gowns, for example, have to pass the AAMI PB70 Level 1 & 2 barrier tests, which are drip tests and lower threshold hydrostatic tests performed in accordance with AATCC 42 and 127 that gauge the material’s permeability. Class II gowns have to qualify for AAMI PB70 Level 3 & 4, a much higher threshold. This requires both the drip test and hydrostatic test in accordance with AATC 42 and 127 along with other tests that indicate permeability to synthetic blood as well as pathogens (ASTM F1670 and F1671). Class II gowns also require CFR and ANSI testing for tensile and abrasion resistance.

FDA Registration for PPE Manufacturing

Registering with the FDA is a straightforward process; you simply fill out a form and pay a fee. The more complex aspect is filing for a 510K pre-notification, which is required for all non-exempt medical devices and can take as long as six months. (Read more about how the FDA regulates PPE.)

During the COVID-19 pandemic, the FDA has exempted both Class I and Class II gowns from pre-notification requirements. Technically, this means that you can sell gowns at the Class I and Class II level without issue from the FDA. However, if you’re looking to manufacture PPE in the long-term, it’s advisable to acquire the 510K pre-notification status, which allows you to sell your PPE gowns after the pandemic exemptions lift. 

Additional Manufacturing Requirements

Despite the exemptions, you must still meet internal manufacturing requirements, including an extensive quality manual and labeling specifications required by the FDA. The FDA recommends, but does not require, ISO 13485 certification. ISO 13485 sets the quality management system requirements for organizations that provide medical devices.

The American PPE Manufacturer Association (APMA) is your trusted source for advocacy, education and resources to support your American Made PPE manufacturing operations. Our experts are here to help you navigate the FDA approval process and testing requirements for masks, gowns and more. Explore our resources library and join our thriving community today.