Medical Product Introduction

About Masks

The World Health Organization recommends that all healthcare workers treating people with the virus wear the surgical masks, along with gloves, goggles and gowns. Surgical masks are thought to be more effective in a clinical setting because they are accompanied by other protective equipment and stringent hygiene practices.

The masks are also frequently replaced – surgical masks are not designed to be used more than once.

N95 respirators offer more protection. Such devices are designed to prevent 95 per cent of small particles from entering the nose and mouth area. But they only work if they fit properly, and aren’t suitable for children or people with facial hair.

N95 respirators can also make it more difficult for a person to breathe, so could be dangerous for someone showing symptoms of infection of the new coronavirus, which include coughing and shortness of breath.

About Medical Gowns

Gowns are examples of personal protective equipment used in health care settings.  They are used to protect the wearer from the spread of infection or illness if the wearer comes in contact with potentially infectious liquid and solid material. They may also be used to help prevent the gown wearer from transferring microorganisms that could harm  vulnerable patients, such as those with weakened immune systems.  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:

○Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit

○Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab

○Level 3: Moderate risk, to be used, for example, during 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)

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. Product names are not standardized.

Surgical Gowns

A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.  A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards.  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.  Surgical gowns can be used for any risk level (Levels 1-4).  All surgical gowns must be labeled as a surgical gown.

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 that requires a 510(k) premarket notification.  As referenced in Figure 2, all areas of the surgical isolation gown except bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated.  All seams must have the same liquid barrier protection as the rest of the gown.  Additionally, the fabric of the surgical isolation gown should cover as much of the body as is appropriate for the intended use.

Non-Surgical Gowns

Non-surgical gowns are Class I devices (exempt from premarket review) intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination. 

Like surgical isolation gowns, non-surgical gowns should also cover as much of the body as is appropriate to the task.  As referenced in Figure 2, all areas of the non-surgical gownexcept bindings, cuffs, and hems are considered critical zones of protection and must meet the highest liquid barrier protection level for which the gown is rated.  All seams must have the same liquid barrier protection as the rest of the gown.