Whether you need isolation gowns for a hospital or you’d want to sell them, this ultimate guide will walk you through the proper selection and purchase of isolation gowns.
Medical PPE and protective clothing is a hot commodity right now as hospitals and healthcare centers worldwide battle against the COVID-19. In September 2020, it was even forecasted to have a market growth of 20.30% for the next 5 years - an exponentially higher forecast than that of 2018’s, which is at 5.46%.
Did you know there are different types of protective isolation gowns available? Knowing how to choose for your staff or business is highly important to optimize its use especially in times of surge capacities. You’d also need to be aware of the standards and regulations for its market clearance to prevent refunds or worse, losses. Hence, you’d definitely need this one-stop guide.
In this article, we included the following topics:
What are isolation gowns used for?
Selecting the right type of gown
Different standards and tests for isolation gowns (ASTM/AAMI/ANSI)
Import/export regulations for isolation gowns
Purchasing isolation gowns from China
What are Isolation Gowns?
Isolation gowns are personal protective equipment (PPE) used in the healthcare settings such as in hospitals and medical centers. They are designed to provide a safety barrier between a surgeon/doctor and patient.
In today’s situation, these protective gowns are used as an infection control device to prevent the spread of the COVID-19. Hence its high demand, previous supply shortage and CDC’s strategies in optimizing its supply
What is an Isolation Gown Used for?
The FDA emphasizes 2 uses of isolation gowns as a two-way protective clothing:
Protects the wearer from getting infected by biological liquids or solids, droplets, and fluid penetrations and,
Prevents the doctor/healthcare professional from transferring infectious microorganisms to their patients during patient rounds
Selecting the Right Type of Isolation Gowns & Protective Clothing
1. Perform Risk Assessment
First is to determine the risk level in each area or department of your establishment. This also means assessing if the area, the medical and exam procedures/applications and other activities such as testing or lab work pose low risk, medium to high risk of infection transmission.
Low Risk Applications & Procedures
For low risk applications, a protective gown or non-surgical gown with an AAMI Level 1 or 2 may be given to staff. But note that isolation gowns need to be sterile for procedures which require sterile applications.
Low risk applications and procedures may include:
Non-sterile compounding
Non-hazardous preparations
Routinary laboratory testing
Bathing clients
Handling non-infectious clients
R&D work
Housekeeping and janitorial duties may also be categorized as low risk applications but if your staff needs to clean the rooms of patients with known infection, they must be given protective gowns with a higher degree of protection.
Medium to High Risk
Medium to high risk applications may include the following medical procedures:
Endoscopy procedures
Bronchoscopy procedures
Decontamination of medical devices
Emergency room procedures
Inserting IV lines
If any of the following medical applications or similar procedures are involved, you would need to choose isolation gowns with an AAMI Level 3 protection or surgical-grade gowns.
Note that in these types of areas or medical applications, isolation gowns may need to be replaced as soon as there is visible contamination.
High Risk
High risk areas and applications are where you would expect a significant amount of blood, splatters and high fluid pressures your staff is being exposed to. Medical procedures may include but not limited to:
Endoscopy procedures
Bronchoscopy procedures
Decontamination of medical devices
Emergency room procedures
Inserting IV lines
2. Selection by Isolation Gown Application
Protective Gown
Protective gowns may be reusable gowns or disposable gowns. Hospital visitors, non-infectious patients, or clinical staff can wear protective gowns. These are worn for low risk applications which provide single isolation.
Non-Surgical Isolation Gown
Non-surgical disposable isolation gowns can be used in situations where chemicals and low risk fluids are present. It can provide two way protection and isolation between a patient and a medical staff.
Surgical Gown
A surgical gown is an FDA-regulated product which needs special documents, proof of test and proper labeling before marketed. That’s because these are used for intensively critical situations where blood draws, transmission of microorganisms and body fluids can infect the wearer.
Due to the higher level of protection it can provide, it can only be used by healthcare professionals doing operations or handling infected patients.
Surgical Isolation Gown
Surgical isolation gowns provide a protective barrier from deadly diseases or infected blood transmissions from patients. It provides two-way protection
Chemotherapy Gowns
Chemotherapy gowns are intended for healthcare staff handling chemotherapy agents and hazardous drugs. Medical staff preparing and administering these drugs should wear chemotherapy gowns, which are designed to provide the highest degree of protection.
3. Knowing the Critical Zones of Isolation Gowns
Isolation gowns are generally categorized according to its liquid barrier protection as standardized under the AAMI PB70 and at their critical zones. These critical zones are important as it sets the difference between an unrated gown and a rated gown.
Critical Zones for Surgical Gowns
A, B and C should have a barrier of protection of at least AAMI Level 1.
The critical zone area comprises at least A and B.
Area D (back) can be made of a nonprotective material.
Non-Surgical Isolation Gowns
A, B, C and the seams, except the cuff, bindings and hems, need to have a barrier protection of at least Level 1.
4. Choosing the Right Level of Barrier
Here are 4 classifications of AAMI PB70:2012 for isolation gowns.
|
AAMI PB70 |
Description |
Use/Application |
| Level 1 |
|
Standard hospital non-hazardous, non-infectious procedures |
| Level 2 |
|
Suturing, Blood drawing from a vein, Pathology laboratories, Intensive care unit |
| Level 3 |
|
Emergency Room, Arterial blood drawing, Inserting an IV, Trauma |
| Level 4 |
|
Non-Airborne Infectious diseases, Pathogen resistance, long periods of exposure over Large amounts of fluid |
5. Material Selection
Isolation gowns are usually made from spunbond synthetic material or cotton. If you want to buy reusable apparels, gowns made from cotton are usually marketed as reusable and washable.
On the other hand, for surgical applications and intensive care units, disposable isolation gowns are highly common. You can choose from a variety of disposable gowns offering varying levels of fluid resistance.
6. Sterile vs. Clean Gowns
Clean gowns are used for isolation, while sterile isolation gowns are reserved for intensively dangerous procedures like surgeries. A clean isolation gown will do for COVID-19 infection control.
Standards and Tests for Isolation Gowns
ASTM F2407
Surgical Isolation Gowns are tested according ASTM F2407 – 06(2013)e1 (Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities). This test gives focus on the surgical isolation gown’s properties, namely: seam strength, tear resistance, evaporative resistance, lint generation, and water vapor transmission.
|
Test |
Standard(s) |
| Tensile strength | ASTM D5034 |
| Tear resistance | ASTM D5587 |
| Seam strength | ASTM D751 |
| Lint generation | ISO 9073 part 10 |
| Water vapor transmission (breathability) | ASTM F1868 part B |
ANSI/AAMI PB70
The AAMI standards give classification to medical gowns and drapes according to their liquid barrier performance.
Moreover, the AAMI validates the protection level the medical apparel can provide. Regardless of type, the isolation gown is needed to have a product label describing the level of protection based on the given risk levels.
Import/Export Regulations for Isolation Gowns
Isolation gowns are classified as Class I medical devices. That means these products don't need a 510(k) Premarket Notification. This is a submission made to the FDA to show that these products are safe and effective as other tested and verified products that are already existing in the market.
However, Surgical Isolation Gowns are classified as Class II Medical devices. These products will need a 510K before premarket notification. This is because Surgical Isolation Gowns are included as FDA-regulated devices, according to 21CFR812.2.
On the other hand, other non-surgical isolation gowns classified as Class I FDA-regulated are subject to the FDA Code of Federal Regulations for Medical Devices (21CFR812.2).
Guidelines in Purchasing Isolation Gowns from China
China is one of the most abundant sources of high-quality isolation gowns such as patient gowns, non-surgical gowns, sterile gowns, surgical gowns, and surgical isolation gowns.
Are you interested in buying wholesale isolation gowns from a manufacturer in China? Here are a few guide questions for you before you make a purchase.
1. Can the Surgical Gown Manufacturer Export its Products?
If the surgical gown manufacturer wants to export to the US or Europe, the exporter should follow the Chinese export regulations first.
With this, the manufacturer gets approval from China's National Medical Products Administration (NMPA) first. If the company does not get approved, they will be held by customs, and they cannot export its products to other countries.
2. Can the Surgical Gowns Be Imported to the US?
When they are imported in the USA, surgical gowns and surgical isolation gowns will need a 510(k) Premarket Notification Clearance before they can be cleared by the FDA. This will certify that these products will be as safe and effective as other products existing in the market.
These medical products are classified as Class II medical devices under the FDA Code of Federal Regulations for Medical Devices (21CFR812.2) in the US.
Moreover, if gowns and drapes are marketed as ‘sterile’, the manufacturer should include information on their sterility. These sterilization and packaging sterility methods will then be included in the information for the 510 (k) clearance
3. Can the Surgical Gowns Be Imported to Europe?
European standards require a CE mark for imports of surgical grade products, including surgical isolation gowns. Surgical gowns are classified as MD Class I or Class II and must conform with the EN 13795-1:2019 .
4. What are Your Payment & Delivery Options?
Payment options for wholesale purchase of gowns usually require T/T, L/C, D/A, Western Union or other forms. Manufacturers may also accept FOB or CIF. Usually, the delivery time ranges from 15 to 30 days for bulk orders.
Summing Up
We hope you were guided by this article on how you can select and purchase isolation gowns for your hospital or retail business.
Since isolation gowns are being tremendously marketed in many names (hospital gowns, procedural gown, etc.), it becomes even more confusing to select the right type of gowns. Hence, we recommend looking at the product label first and confirming its intended use before you make a purchase.
Ready to buy isolation gowns? HisoMedical is an isolation gown manufacturer and exporter from China with 11 years experience in PPE manufacturing and supply. We offer high-quality isolation gowns, made from PP+PE, SMS and fluid-resistant multi-ply material.
Contact us for a quick quotation!
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