"To create a safety barrier between patients and medical professionals, medical gowns/isolation gowns or other protective gowns are worn by medical professionals as personal protective equipment (PPE)"
FDA Classifies Protective Gowns Into 3 Categories
SURGICAL GOWNS AND SURGICAL ISOLATION GOWNS ARE CLOSELY REGULATED
- surgical gowns
- surgical isolation gowns
- non-surgical gowns
Medical gowns intended for use in health care settings may have various names, include surgical gowns, isolation gowns, surgical isolation gowns, non-surgical gowns, procedural gowns, and operating room gowns.
Materials for Disposable Gowns
DISPOSABLE GOWNS ARE COMMONLY MADE FROM THESE NONWOVEN MATERIALS:
- polypropylene
- polyester
- polyethylene.
Rather than sewn, the garments are typically assembled using thermal, chemical, or mechanical seaming.
Medical Gown Level of Protection
THE STANDARD DESCRIBES THE BARRIER PROTECTION LEVELS OF GOWNS AND OTHER PROTECTIVE APPAREL INTENDED FOR USE IN HEALTH CARE FACILITIES
In 2004, the FDA recognized the standards from the American National Standards Institute & Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, The standard describes the barrier protection levels of gowns and other protective apparel intended for use in health care facilities :
- Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, a cover gown for visitors, or in a standard medical unit
- Level 2: Low risk, to be used, for example, during the blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
- Level 3: Moderate risk, to be used, for example, during the arterial blood draw, inserting an intravenous (IV) line, in the Emergency Room, or for trauma cases
- Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)
When choosing gowns, make sure that you look for the product labeling, and understand the intended use of levels of protection.
