Posted by Ken Lim on

The Food and Drug Administration (FDA) defines isolation gowns as a gown intended to protect healthcare patients and personnel from the transfer of microorganisms, body fluids, and particulate material. Isolation gowns serve as a physical barrier to the transfer of microbes and other potentially infectious materials.

Currently, there is confusion in the marketplace over the terminology of gowns – isolation gowns, cover gowns, precaution gowns, and protective gowns even though these terms are not used by the FDA and CDC in classifying protective apparels.

It is very necessary that users understand the difference in these terms to enable them make correct choices when making orders as choosing the wrong apparel results poses the risk of insufficient protection and infection. 

A "cover gown" is an article of clothing (not a medical device) worn over an operating room (OR) scrub suit/dress when OR personnel leave the operating room for reasons such as lunch breaks. 

"Protective gown" and "precaution gown” are also used to define isolation gowns in the marketplace. Sometimes, protective gowns are used to refer to impervious gowns with a high level of protection.

Isolation gown is however, the correct term to use in describing apparel meant for isolating cases to protect health care workers from the transfer of microorganisms.

Many different types of isolation gowns are currently available to healthcare professionals with each type offering varying protection levels. The choice of isolation gown is based on;

  • The nature of the patient interaction, including the anticipated degree of contact with infectious material and potential for blood and body fluid penetration of the barrier, anticipated volume of blood, body fluids. 
  • Duration of procedure or activity being performed
  • The nature of the fabric of the gown. The degree of fluid resistance and the reusability of a gown should be put into consideration when you're making a choice.

The FDA classified exposure levels which determine the appropriate type of gown to use. The defined levels of protection are namely; 

  • Level 1: Minimal risk situations such as basic care, standard isolation, visitation.
  • Level 2: Low risk situations such as during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
  • Level 3: Moderate risk situations as during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases
  • Level 4: High risk such as during long, fluid intense procedures, surgery, when pathogen resistance is needed or infectious diseases are suspected (non-airborne)

The type of gowns used at each exposure level varies as suggested by the FDA and are namely;

  • Surgical gowns: Surgical gowns can be used for any risk level (Levels 1-4). According to national standards, critical zones of protection in a surgical gown include the front of the body from top of shoulders to knees and the arms from the wrist cuff to above the elbow. 
  • Surgical Isolation Gowns: Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device. All areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and the fabric must cover as much of the body as possible.
  • Non-surgical gowns: This refers to the commonly called isolation gown. They are Class I devices (exempt from premarket review) and are used when there is low or minimal risk of infection.  

Shaphargroup's Isolation Gowns meets Level 1-4 PP, PE, PP+PE, and SMS meets all FDA, ANSI/AAMI standards. 

Isolation gowns found in the marketplace today are produced from a variety of fabrics and a wide range of fibers. 

Isolation gowns are generally classified as “disposable/single-use” or “reusable/multi-use”. Disposable gowns are widely used in the US, while Multi use gowns are used more In Europe. 

Disposable isolation gowns are typically constructed of nonwoven materials alone or in combination with materials that offer increased protection from liquid penetration, such as plastic films. The basic raw materials typically used for disposable isolation gowns are various forms of synthetic fibers (e.g. polypropylene, polyester, polyethylene). 

Reusable isolation gowns are typically made of 100% cotton, 100% polyester, or polyester/cotton blends. Reusable (multi-use) gowns are laundered after each use and can typically endure up to 50 washing and drying cycles. 


The performance of gowns is tested using consensus standards such as the American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 and the American Society for Testing and Materials (ASTM) F2407. These standards consider parameters such as, tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission. 

You can access these information and hence make the perfect choice by checking the product label.

Recommended steps for wearing a Isolation gown, 

  • First select the appropriate type for the task and the right size for
  • The opening of the Isolation gown should be in the back; 
  • Secure the gown at the neck and waist. 
  • If the Isolation gown is too small to fully cover your torso, use two gowns. Put on the first gown with the opening in front and the second gown over the first with the opening in the back. 

Recommended steps for removing a gown:

  • Unfasten the gown ties with the ungloved hands. 
  • Slip hands underneath the gown at the neck and shoulder, peel away from the shoulders. 
  • Slip the fingers of one hand under the cuff of the opposite arm. Pull the hand into the sleeve, grasping the gown from inside. Reach across and push the sleeve off the opposite arm. 
  • Fold the gown towards the inside and fold or roll into a bundle. (Only the “clean” part of the gown should be visible.) 
  • Discard into waste or linen container, as appropriate.

For us at ShapharGroup, we seek to make sure you make the correct choice when making selection for your PPEs as customer health and protection is our topmost priority. You could contact us for more information on the perfect Isolation gown to suit your description. 

Email: info@shaphargroup.com  

Phone number: +13477418333, +85281912961

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