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Know the Products You Use - FDA 510K Approval

Updated: Mar 10, 2022


Have you ever read the FDA approval (510k) for the products you are using? It may surprise you how much information is in the documents. For example, the intended use, performance testing, which may include decontamination and sterilization protocols, technical characteristics are just some of the topics listed. The FDA approved many products we use in sterile processing based on another product that is similar and is already in use. The term used for this approval is "substantially equivalent."An outline for an SE request includes:

Listing of design features

Listing of ingredients

Listing of materials

Description of heating source

Description of composition

Harmful and potentially harmful constituents (HPHCs)

Laboratory accreditation

Storage conditions of products (both the predicate and new)

Health information

To learn more visit

Also, you can Google your product and use the term "510k approval" to learn about the products you are using.

At Evolved Sterile Processing, our consultants have a greater focus on sterile processing. With our decades of experience, we will help you develop better processes and educational resources for your staff.

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