Below you will find answers to some of the frequently asked questions we receive.
What PPE products do you offer?
Our products include AAMI Level 1-4 gowns (sterile and non-sterile), lab coats, 3-ply surgical masks, face shields, and other PPE items. We are dedicated to constantly expanding our product offerings with a focus on those product lines that will provide Stronghold partners with the greatest value. For specific product questions, do not hesitate to contact us for a personalized quote.
Do your products have FDA 510(k) clearance?
Stronghold offers an expansive portfolio of personal protective equipment. Many of our products are FDA Class I devices exempt from 510(k) clearance or have been authorized for use by the FDA under Emergency Use Authorization. FDA 510(k) Premarket Notification is required for all non-exempt medical devices that fall into risk Class II. Stronghold ensures compliance with this requirement by only providing our customers with Class II devices that have received FDA 510(k) Premarket Notification.
What payment terms do you offer?
Stronghold is proud to offer our approved customers payment terms ranging from net 10 to net 30 days.
Do you accept letters of credit?
Stronghold is happy to accept irrevocable documentary letters of credit based on mutually agreed upon terms.
Do you have questions about medical gown protection standards and Stronghold’s AAMI-rated gowns?
Below you will find answers to some of the frequently asked questions we receive about medical gown classifications and rating.
What is AAMI?
AAMI refers to the Association for the Advancement of Medical Instrumentation. AAMI is an international standards organization that develops and publishes technical standards for the medical device industry.
What testing is required to claim a gown is “AAMI rated”?
AAMI PB70:2012 details specific test methods and passing criteria in order to label an isolation gown as AAMI 1, 2, 3, or 4 rating. A summary of the required testing is in the table below.
AAMI Levels and Testing Methods
|AAMI Level||Test Method||Criteria|
|1||AATCC-42: Water Resistance: Impact Penetration||≤ 4.5g|
|2||AATCC-42: Water Resistance: Impact Penetration
AATCC-127: Water Resistance: Hydrostatic Pressure
|3||AATCC-42: Water Resistance: Impact Penetration
AATCC-127: Water Resistance: Hydrostatic Pressure
|4||ASTM F1671: Viral Penetration||Pass|
What is AAMI PB70:2012?
PB70:2012 is a publication by AAMI detailing the liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. It rates gowns in increasing levels of protection from level 1 (lowest) through to level 4 (highest). It has become recognized as the global standard for protection criteria of isolation gowns throughout the world.
What is the purpose of an isolation gown?
A medical gown is intended to protect healthcare personnel and patients from the transfer of micro-organisms and particulate material.
I’ve heard other terms used for medical gowns like “hospital gowns,” “disposable gowns,” “surgical gowns,” “protection gowns,” etc. Are there differences between the terms used for gowns?
- Medical Gowns, Isolation Gowns, and Hospital Gowns
These gowns are all members of the same product family and offer protection against the transfer of microorganisms and particulate material. Depending on the level of protection of the product, they may be used for anything from janitorial work to being worn by visitors to healthcare providers changing dressings. They have a wide range of applications and styles that can be tailored to the end user’s needs.
- Reusable Gowns
Reusable gowns are typically made from fabric and can be disinfected, cleaned and re-worn. Depending on the specific type of gown and its protection level (e.g. surgical, isolation, patient etc.) it may have a limited number of wearing and cleaning cycles before it must be disposed of. These are typically made of woven fabrics like cotton or other synthetic fibers.
- Single-use Gowns
These gowns are disposed of after use. This makes their use and lifecycle significantly more straight forward from a facilities management perspective by avoiding the need to maintain or contract potentially costly laundering services. These as a rule of thumb tend to be made of nonwoven polymers and/or films.
- Surgical Gowns
In the United States, the FDA’s approach to the term Surgical Gown is one more based on its protection level as opposed to its name. For example, a “surgical isolation gown” may not be sterile and may be used in areas where there is a need for larger critical zones than traditional surgical gowns. For further details, refer to “Requirements Concerning Gowns Intended for Use in Health Care Settings”.
How long is my medical gown effective? When should I replace or dispose of a medical gown?
All Stronghold medical gowns are single-use. This means gowns should be disposed of and replaced if any type of fluid has soiled it, an object has penetrated the material, or if there is any type of abrasion on the gown.
Is the fit of an isolation gown important?
Yes, the fit of a medical gown is very important. If a medical gown does not fit properly, it can be hazardous for various reasons:
- If the isolation gown is too large; it can cause a tripping hazard for the user.
- If there is excess exposed skin around the neck opening of the isolation gown, it is likely too large.
- If a gown is too small for the user, they will not be properly protected. A gown that is too tight inhibits the user from moving freely, as well as presents risks of ripping through the gown and being exposed to harmful contaminants.
What are critical zones?
Critical zones are the areas of the gown that are expected to come into contact with fluid. For example under PB70, a surgical gown’s minimum critical zone includes the front of the gown (chest to knees) and sleeves. Conversely, for an isolation gown, the critical zone is the entirety of the gown minus the cuffs, hems and bindings. Stronghold’s AAMI rated isolation gowns are tested to the applicable standards on the material, at the seams, and on the belt attachment location. This ensures that the entire gown passes the AAMI standards.
What level of protection do Stronghold Medical Gowns offer?
Stronghold medical gowns cover all protection levels from unrated cover gowns to AAMI 4 rated isolation gowns (sterile and non-sterile options). Stronghold also offers an extensive collection of open back gowns manufactured with varying levels of protection. For further details on our various gown lines, contact us
Need information regarding best practices, shelf-life, or usage instructions for Stronghold’s line of gowns?
Below you will find instructions and general information for how to best use Stronghold’s medical and isolation gowns.
A medical gown is typically used in a hospital or clinic environment where you might be exposed to microorganisms and particulate matter in a sterile environment. The medical gown is designed to protect personnel and patients from the transfer of these microorganisms and particulate material in a sterile environment.
When doffing a medical gown leaving your gloves on and pulling the gown off according to following doffing instructions will allow you to safely contain any contaminants.
How do I put on (don) and take off (doff) my gown?
- Check to see if your facility has guidance on how to don and doff PPE. The procedure to don and doff should be tailored to the specific type of PPE that you have available at your facility.
- If your facility does not have specific guidance, the CDC has recommended sequences for donning and doffing of PPE.
- It is important for Health Care Providers (HCP) to perform hand hygiene before and after removing PPE. Hand hygiene should be performed by using alcohol-based hand sanitizer that contains 60-95% alcohol or washing hands with soap and water for at least 20 seconds. If hands are visibly soiled, soap and water should be used before returning to alcohol-based hand sanitizer.