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how the FDA 510K classifies personal lubricants?


Not everyone needs the product, but which also widely used in couple who are more than 40 years. Personal lubricants are governed and cleared by the FDA for sale and are classified as either A Class I or A Class II Medical Device, depending on the use or what the formula contains.

Since the lubricant is absorbed by body and can enter the bloodstream, the government must make sure the product has done its due diligence in having the formula and ingredients tested by FDA approved laboratories. This ensures the ingredients and formula do not have adverse effects on humans. There are currently 5 different FDA classifications for Personal Lubricants.

More info pls read the following link:

https://www.linkedin.com/pulse/how-fda-classifies-personal-lubricants-what-510k-andreas-maulhardt/

welcome inquiry us if you plan has own brand personal lube, we can custom work for you.

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