An AAMI Level 3 surgical gown sits near the top of the ANSI/AAMI PB70 scale, the consensus standard FDA recognizes for rating the liquid barrier performance of protective apparel and drapes used in health care facilities. This guide explains what Level 3 means, when it is typically used, and how the Bodygard SFS Level 3 sterile surgical gown fits in.
What AAMI PB70 Level 3 means
AAMI PB70 sorts protective apparel into four levels by how well the material stops liquid. Level 1 is the lowest and Level 4 is the highest. Level 3 is described as moderate risk. To reach Level 3, the material must pass two water tests: AATCC 42 water impact (1.0 g or less) and AATCC 127 hydrostatic pressure (50 cm or more). In practice, that means resistance to spray plus some resistance to soaking under pressure.
Two points are easy to miss. First, the level measures liquid barrier only; strength, comfort and breathability are tested separately. Second, the level applies to the critical zones. For a surgical gown, these are the front of the body from the top of the shoulders to the knees, and the arms from the cuff to above the elbow. The back of a surgical gown may be non-protective.
When a Level 3 gown is used
The AAMI risk descriptions give examples of Level 3 situations: arterial blood draw, inserting an intravenous (IV) line, the emergency room and trauma cases. These are examples, not a rule. Which level a procedure needs is up to your facility's infection prevention team. For long, fluid-intense procedures, or when viral-penetration-tested apparel is required, a Level 4 gown is the usual step up. Our guide Level 3 vs Level 4 Surgical Gowns compares the two levels in detail.
The Bodygard SFS Level 3 sterile surgical gown
The Bodygard SFS AAMI Level 3 Sterile Surgical Gown is FDA 510(k) cleared (K202845). It is available as an EN 13795 High Performance / AAMI Level 3 gown and is suitable for most procedures. The SFS65 gown is made from a breathable, textile-like material that is comfortable to wear.
- Ergonomic fit: shoulder pleats and ergonomic sleeves allow freedom of movement
- Glove-compatible cuff that helps prevent gloves from sliding off
- Specially treated to repel low-surface-tension fluids
- Available in Standard or High Performance, with an impermeable front and sleeves for added protection against strike-through
- Can be included in procedure trays to support OR efficiency
Surgical gown or isolation gown?
A surgical gown is regulated by FDA as a Class II medical device that requires a 510(k) premarket notification. It is worn by health care personnel during surgical procedures to protect both the patient and the staff from the transfer of microorganisms, body fluids and particulate matter. Product names such as isolation gown, procedure gown and cover gown are not standardized, so always check the label for the intended use and the AAMI level.
Request pricing or samples
For sizes, case quantities and bulk pricing, see the Level 3 gown product page or contact our sales team.
28 September 2021
