Product Information
Quality Standards: ASTM D 6319:2019 or EN 455-1 and EN 445-2
Adopted by the U.S. Food and Drug Administration (FDA)
ASTM D6319: This American Standard covers certain requirements for nitrile rubber gloves used in medical applications. Standard specifies various test methods including sterility testing, physical dimensions testing, physical requirements testing, powder residue, and powder limit testing
EN 455: European Standard:
Part 1: Requirements and testing of gloves for freedom from holes
Part 2: Requirements and tests for physical properties
Part 3: Requirements and tests for biological evaluation
Part 4: Requirements and testing for shelf-life determination
All Rights Reserved to Aavvie
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.