Aug 10, 2010

Latex Free Labeling

For a new device we spent a bit of time working on "Latex Free" labeling.  From the FDA point of view (801.437), the key point is natural rubber.  The term "natural rubber" includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation.  So while your label coatings may contain latex to give them that glossy look, its most likely synthetic latex (although not always), and you're off the hook.

ASTM D6499 (LEAP assay) can be used to determine if your device tests positive for natural latex and is reasonably cheap insurance that your product is safe.

Recently BS EN980 added a Latex symbol for devices that contain latex.  However, there isn't a corresponding recognized symbol for latex free, so the words Latex Free seem like the way to go.  Many companies, including GE and 3M, use the Latex symbol with an X through it.

While it is easy enough to lay off the latex gloves in your assembly area, what are your suppliers or their suppliers doing?  Although it seems far fetched, a polymer resin handled with someone wearing latex gloves could make its way into your molded part.  I can assure you, tracking down this information is a pleasant way to spend a week.  Updating your Certificate of Conformance requirements from the product development seems like the easiest way to go.

Update 6/26/2013:  The FDA has issue a draft guidance, see this issue revisited here.


Guantes DE Nitrilo said...

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