Level 3 Isolation Gown – Maximum Protection • For use when expected risk of exposure to fluid is moderate • Meets ANSI/AAMI PB70:2012, AATCC 42 & AATCC 127 Level 3 requirements • Heavy-weight 100% non-woven spunbond polypropylene fabric • Non-Sterile • Recommended for: Drawing arterial blood, inserting I.V.
AAMI Levels and Testing Methods. Gowns are one part of an overall infection-control strategy.A few of the many terms that have been used to refer to gowns intended for use in health care settings, include surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns.In 2004, the FDA recognized the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.” New terminology in the standard describes the barrier protection levels of gowns and other protective apparel intended for use in health care facilities and specifies test methods and performance results necessary to verify and validate that the gown provides the newly defined levels of protection:Regardless of how the product is named (that is, isolation gown, procedure gown, or cover gown), when choosing gowns, look for product labeling that describes an intended use with the desired level of protection based on the above risk levels. To make sure surgical gowns meet the standards set out by these organizations, they undergo a variety of standard tests, including: FLUID AND BACTERIOPHAGE BARRIER (ASTM 1671) Measures resistance of materials used in protective clothing to bloodborne pathogens using viral …
All rights reserved. Looking for other medical products we carry? The ANSI/AAMI PB70 standard includes four standard tests to evaluate the barrier effectiveness of surgical gowns, isolation gowns, and surgical drapes.
As referenced in Figure 1: the critical zones include the front of the body from top of shoulders to knees and the arms from the wrist cuff to above the elbow.
Isolation Gown, AAMI Level-4.
Specifically, ANSI (American National Standards Institute)/AAMI PB70:2012 Materials. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. VitalSource™ GPO: Solutions for oncology and urology practicesVitalSource™ GPO: Solutions for oncology and urology practicesKangaroo™ Accessories with Safe Enteral ConnectionsKangaroo™ Gastrostomy Feeding Tubes w/ Y-Port with Safe Enteral ConnectionsKangaroo™ Multifunctional Port with Safe Enteral ConnectionsKangaroo™ Polyurethane and Argyle™ PVC Feeding TubesThermoreactively Cured Highly Purified Synthetic HydrogelsThermoreactively Cured Natural Polysaccharide KarayaArgyle™ Neonatal-Pediatric Peripherally Inserted Central Catheters (PICCs) & Trays
Our open-back disposable gowns are made from high quality polypropylene (PP) material (30+/- 2 gsm). AAMI also requires a closed back for isolation precautions. Conformance with recognized consensus standards is voluntary for a medical device manufacturer. Provides a barrier to larger amounts of fluid penetration through splatter and some fluid exposure through soaking. Halyard Isolation Gowns are designed to protect you and your patients from microbial contamination and adhere to AAMI PB70 performance guidelines.
Specifications: For use when expected risk of exposure to fluid is high; Meets ANSI/AAMI PB70:2012, AATCC 42 & AATCC 127 Level 3 ASTM F1671 Level 4 requirements; Heavy-weight 100% non-woven spunbond polypropylene fabric; Non-Sterile ; Recommended for:† Surgical Settings; ER, Trauma, Burn Units, …