Understanding the AAMI level 4 surgical gown

*The front belt attachment must pass if it is in the front chest critical zone.

Sleeve

Sleeve seam

Front belt* attachment point

Critical zones that must pass:

What does it take to become an AAMI level 4 surgical gown?Protective apparel, including surgical gowns, are governed by a set of standards

and test methods that all manufacturers must meet.

These standards are established by AAMI (The Association for the Advancement of Medical Instrumentation). Specifically, ANSI (American National Standards Institute)/AAMI PB70:2012 is the standard that establishes a classification system (levels 1-4) for protective apparel used in health care facilities, including surgical gowns, based on liquid barrier performance using standardized test methods. The U.S. Food and Drug Administration (FDA) has adopted ANSI/AAMI PB70:2012 as the standard by which all surgical gown manufacturers must abide.

Testing the gownAAMI standards require a surgical gown to pass ASTM F1671 in the critical zones in order to be labeled an AAMI level 4 surgical gown.

What areas are included in the critical zone? There are typically 4 different areas that must pass within the critical zones, including two in the front chest and two on the sleeves. If a product passes ASTM F1671 in all applicable areas, then it qualifies as an AAMI level 4 surgical gown.

Front chest

Within that standard, AAMI has identified ASTM (American Society for Testing and Materials) F1671 as the key test requirement that a surgical gown must pass in order to be labeled AAMI level 4.

What is ASTM F1671? This test is called the “Resistance of Materials used in Protective Clothing to Penetration by Blood Borne Pathogens”. This is a pass/fail test and an AAMI level 4 surgical gown must pass this test.

Least protective Most protective

AAMI levels

Offering AAMI level 4 protectionDoes Cardinal Health offer an AAMI level 4 Surgical Gown?Yes. We offer three different AAMI level 4 surgical gowns, including the Cardinal Health™ SmartGown™ Surgical Gown, a breathable film AAMI level 4 surgical gown.

Does Cardinal Health have a 510(k) for the Cardinal Health™ SmartGown™ Surgical Gown?Yes. The Cardinal Health™ SmartGown™ Surgical Gown received 510(k) clearance in May 2015.

Is the Cardinal Health™ SmartGown™ Surgical Gown an AAMI level 4 surgical gown?Yes. The 510(k) clearance, which includes the ASTM F1671 test results, supports the AAMI level 4 classification for this product.

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Cardinal Health™ SmartGown™ Surgical Gown

Want to know more about AAMI standards? Ask your Cardinal Health sales representative for more information and a detailed explanation of the requirements.

cardinalhealth.com/surgicalgowns

© 2017 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE and SMARTGOWN are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Lit. No. 2PERI16-611762 (03/2017)