About AAMI PB70 Level-3 Surgical Gown

FDA 510(k) Level 3 Surgical Gowns

Surgical gowns are a critical component of personal protective equipment (PPE) used in healthcare settings. In the United States, the Food and Drug Administration (FDA) classifies these gowns into different levels based on their liquid barrier protection capabilities. Level 3 surgical gowns are specifically designed to provide moderate barrier protection against fluid penetration.

For a manufacturer to market a Level 3 surgical gown in the U.S., they must demonstrate that their product is "substantially equivalent" to a legally marketed predicate device. This process is known as the 510(k) premarket notification. The FDA's classification is based on the ANSI/AAMI PB70 standard, which outlines the test methods and performance requirements for liquid barrier protection.

A Level 3 gown must meet specific performance criteria under the following tests:

• AATCC 42 (Impact Penetration Test): This test measures the amount of water that can penetrate the gown material when subjected to a water spray.

• AATCC 127 (Hydrostatic Pressure Test): This test measures the gown's resistance to water penetration under pressure.

To be classified as Level 3, the gown must pass both tests, demonstrating a moderate level of liquid barrier protection. This means the material is highly resistant to fluid penetration, especially in the critical zones (the front of the body and the sleeves). 

The following are the test results of our surgical gowns:

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