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Disposable Surgical Gowns

Our Level 1, 2 and 3 gowns are intended to be used when minimal, low, and moderate fluid barrier protection is needed. Level 4 gowns are prepared for the highest fluid and microbial barrier protection to protect the user against lengthy, fluid-intensive procedures and reduce the risk of potential blood-borne pathogens.

Description

Our Level 1, 2 and 3 gowns are intended to be used when minimal, low, and moderate fluid barrier protection is needed. Level 4 gowns are prepared for the highest fluid and microbial barrier protection to protect the user against lengthy, fluid-intensive procedures and reduce the risk of potential blood-borne pathogens.

AAMI PB70 GUIDELINES

Level Test Method Test Definition Requirement Expected Barrier Effectiveness Anticipated Fluid Exposure
AAMI Level 1 AATCC 42 Impact Penetration Measures the ability of a material to resist water penetration under spray impact Water impact < 4.5g Minimal water resistance (some resistance to water spray) Minimal Fluid Levels
AAMI Level 2 AATCC 42 Impact Penetration Measures the ability of a material to resist water penetration under spray impact Spray impact < 1.0g Low water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure) Low Fluid Levels
AATCC 127 Hydrostatic Pressure Measures the ability of a material to resist water penetration under constant contact with increasing pressure Hydrostatic pressure > 20cm
AAMI Level 3 AATCC 42 Impact Penetration Measures the ability of a material to resist water penetration under spray impact Spray impact < 1.0g Moderate water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure) Moderate
Fluid Levels
AATCC 127 Hydrostatic Pressure Measures the ability of a material to resist water penetration under constant contact with increasing pressure Hydrostatic pressure > 20cm
AAMI Level 4 ASTM F1671 Viral Penetration Test Measures the resistance to penetration by blood borne pathogens using a surrogate microbe under conditions of continuous liquid contact Pass Blood and viral penetration resistance (2 psi) High
Fluid Levels

The Association for the Advancement of Medical Instrumentation (AAMI) standards are designed to help medical-device companies meet global standards for the safe use of medical devices. ANSI/AAMI PB70:2012