Product Information
Aavvie® Healthwear™ products are tested for and meet the AAMI Level 4 standard, European Standard: EN13795 High Performance.
-Suggested guidelines are not a substitute for clinician professional judgment and experience.
AAMI levels determined by ANSI/AAMI PB70:2012
Adopted by the U.S. Food and Drug Administration (FDA)
This Standard states that, the acceptable quality limit of latex examination gloves should be 2, 5, a minimum tensile strength of 18 MPa, and a minimum elongation rate of 700 percent.
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AAMI standards require a surgical gown to pass ASTM International 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 four 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 InternationalF1671 in all applicable areas, then it qualifies as an AAMI level 4 surgical gown.