Frequently Asked Questions

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.

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.

Stronghold is proud to offer our approved customers payment terms ranging from net 10 to net 30 days.

Stronghold is happy to accept irrevocable documentary letters of credit based on mutually agreed upon terms.

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.

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

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.

A medical gown is intended to protect healthcare personnel and patients from the transfer of micro-organisms and particulate material.

• 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”.

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.

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.

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.

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