Medical gowns are also known as isolation gowns, surgical gowns, or procedure gowns. These are vital pieces of personal protective equipment for healthcare professionals. They are used for reducing the spread of infection spread through contact with potentially contagious liquid or solid substances and help prevent the wearer from transmitting the infection to patients.
In 2004, the FDA acknowledged the acceptable regulatory standard American National Standards Institute or 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.”
The standard categorizes the barrier protection levels of medical gowns and other PPE items that are used in healthcare centers according to four levels. Since the names of products are not standardized, wearers can choose their gowns by checking the gown labels for the intended use and based on the level of protection required.
Here Are the Four Risk Levels
- Level 1: Minimal risk medical gowns are used during basic treatment and care, standard isolation, for visitors, or in a standard medical unit.
- Level 2: Low-risk gowns are intended for use during the blood draw, suturing, in a pathology lab, or in the ICU.
- Level 3: Moderate risk gowns are to be used during the arterial blood draw, for trauma cases, inserting an Intravenous (IV) line, or in the Emergency Room.
- Level 4: High-risk medical gowns are used during lengthy, fluid-intensive procedures, critical surgeries, or when non-airborne pathogen protection is needed or viral diseases are suspected.
Whether you’re looking for non-surgical and surgical gowns for sale, we are a one-stop solution for all your medical healthcare requirements.
Different Types of Medical Gowns Available
Before you source from non-surgical or surgical gowns manufacturers in the USA, you must understand the different types of gowns available in the market.
All the surgical gowns for sale in the USA are regulated by the FDA as Class II medical devices that need a 510(k) premarket notification. However, in Canada, all medical gowns, including surgical and non-surgical, are categorized as Class I medical devices and are subjected to medical devices rules and regulations.
A surgical gown is protective clothing meant to be worn by healthcare staff during surgical procedures to keep both the patient and healthcare staff safe from the transmission of microorganisms, particulate substances, and body fluids.
All surgical gowns for sale must be labeled accordingly and can be used for any level from Level 1-4.
Areas Protected by Surgical Gowns
The critical areas protected by surgical gowns include the front of the body, which is from the top of shoulders to knees as well as arms, from the wrist cuff to above of the elbow.
Surgical Isolation Gowns
Surgical isolation gowns are used in situations that involve moderate to high risk of infection and need to protect larger critical zones. Surgical isolation gowns are also governed by the FDA as Class II medical devices that need a 510(k) premarket notification. They should cover as much of the body as required.
The key zones protected surgical isolation gowns include all areas except bindings, wrist cuffs, and hems.
Key protection zones of surgical isolation gowns should adhere to the highest level of liquid barrier protection for which the gown has been rated and all layers on the gown must provide a consistent level of liquid barrier protection like the rest of the gown.
If you’re looking for wholesale surgical gown suppliers in the USA, you can contact Co-Defend right away for your requirements.
Non-surgical gowns are regarded as Class I medical devices, and therefore, they do need premarket review. These gowns are meant for protecting wearers against the transmission of pathogens and body fluids in low-risk patient isolation conditions.
Non-surgical gowns are not ideal for surgical procedures, intensive procedures, or conditions when there is a moderate to high risk of infection. Non-surgical gowns must cover most of the body parts as they should.
The critical areas protected by non-surgical gowns include all areas except bindings, cuffs, and hems.
Critical zones on non-surgical gowns must meet the highest level of liquid barrier protection for which the gown has been rated. Also, all seams on the non-surgical gown should offer consistent level of liquid barrier protection like the rest of the gown.
How to Choose the Right Medical Gown?
According to the CDC, here are the following criteria that you need to consider while selecting a medical gown:
- Intended Use – Generally, isolation gowns are preferred the most, however, for procedures that involve limited contamination, an apron is sufficient. However, if there is a risk of arm contamination, you should select a gown. Medical gowns should completely cover the chest, fit appropriately and comfortably over the body, and have long sleeves that perfectly fit the wrists.
- Material of the Gown – Isolation gowns are made of cotton or woven synthetic fabric. The material determines whether the medical gown is washable, reusable, or intended for single use only. Cotton or woven synthetic isolation gowns also provide various levels of fluid resistance. This is another factor that you need to consider before selecting a medical gown. In situations where there is the risk of fluid penetration, a fluid-resistant gown is an ideal fit.
- Patient Risk Levels – Patient risk analysis helps you determine whether you should choose a sterile medical gown or a clean gown that is good enough. Sterile gowns are needed during invasive procedures, for example, inserting a central line. Here, a sterile medical gown would protect the patient as well as healthcare workers.
These are some of the things that you need to consider when selecting medical gowns. Other than these, you need to consider the type of expected exposure, durability, and suitability to meet the task, its size, according to the CDC.
If you’re looking to source from a surgical gown manufacturer in the USA, you may contact us right away!
Co-defend provides a comprehensive range of personal protective equipment, including medical gowns. All of the gowns are from the best surgical gown brands and are ANSI/AAMI PB70:2012 compliant. We provide a wide variety of medical gowns for healthcare organizations, including surgical gowns, non-surgical gowns, and surgical isolation gowns.
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Q.1. What are the qualities of your medical gowns?
Although the best surgical gown brands meet the industry standards for offering effective barrier protection, we are committed to providing medical gowns that have the following qualities:
- Have premium-quality materials that keep the wearer comfortable
- Are uniquely designed to ensure secure closure and easy wear and removal
- Have designs that offer tailored fit and easy movement
- Has a wide range of styles, sizes, lengths, colors, and fabric
- Offers consistent quality, comfort, durability, and perfect fit.
As one of the trusted wholesale surgical gown suppliers in the USA, we make sure that we provide the best-quality surgical gowns for healthcare organizations.
Q.2. What are the performance standards for medical gowns?
The recognized performance standards for medical gowns include the American Society for Testing and Materials (ASTM) standards which help in determining the integrity of the material used for making medical gowns such as tear resistance, evaporative resistance, lint generation, and water vapor transmission. FDA and Health Canada recognize conformance with ASTM F2407.
In the USA and Canada, liquid barrier performance is defined by the American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2012.
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