As a result of the COVID-19 outbreak worldwide, the consumption of Isolation Gowns has significantly increased. However, most of the consumers do not have yet all the basic information in their hands when choosing the right protection for them. That is why, here at We Shield, we are compiling the most important data about Isolation Gowns to help purchasers make the right decision.
Basics about Isolation Gown
Isolation Gowns are a type of PPE normally utilized in the healthcare field or any other medical environment. They are used to protect the purchaser from the spread of different infections or illnesses if the wearer comes in contact with potentially infectious liquid and solid material.
The most accepted form of classification is the consensus standard American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI). This standard defined 4 levels of protection: Level 1- 4. Therefore the classification of Isolation Gowns is always abbreviated as AAMI Level X.
But buyers should be particularly careful about the naming and/or certifications since some suppliers just claim that their Isolation Gowns are Level 2 or Level 3, but that doesn’t mean that their products comply with the ANSI/AAMI Level 2 standard. Always ask for an AAMI Test Report or evidence.
The authorized definition of the usage of different levels of Isolation Gowns in America is given by the FDA:
Isolation Gowns 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.
Isolation Gowns Level 2: Low risk. To be used, for example, during the blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab.
Isolation Gowns 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.
Isolation Gowns 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).
Non-level Isolation Gowns: In practice, non-level gowns are used by nurses and patients in minimal risk situations, those gowns are disposable and typically made by PP or PP + ABS, providing minimal protection against liquid and dust.
The classification of Isolation Gowns is majorly defined by their capability of resisting liquid penetration:
The AATCC 42 test is performed by spray 500 ml of water on the gown specimen on top of a blotting paper if the specimen resists enough water and blotting paper’s increased weight is less than the requirement, it is a PASS.
The AATCC 127 test is for hydrostatic water pressure, the water is pumped to press the specimen and the maximum endurable pressure is recorded. If it over the standard’s requirement, it is a PASS.
In our next article about Isolation Gowns, we will demonstrate how to perform a quick quality check without any professional types of equipment. The requirement on supplier’s qualification majorly depends on whether the products are used in surgical scenarios. If yes, the premarket approval from FDA is needed e.g. 510(k), if not, the product is exempt from premarket approval, but the supplier and product should be listed as well.
At We Shield, we offer Level 2 and 3 Isolation Gowns. If you would like to receive our products catalog and price list, please contact us at (833) 937-4435 or through our email info@weshield.us. If you want to read our previous articles about PPE, click this link.