Not made with natural rubber latex and not made with DEHP symbol

[destroyed9218]

Hi,

Do we require to put not made with latex and not made with DEHP symbol on our labels if the products do not contain latex or DEHP?

My understanding is there is no such requirement. We only sell in the US. Can somebody please help?

 

[EmiliaBedelia]

No, you aren't required to label with latex or DEHP if they are not in the device.

For latex, refer to:

https://www.fda.gov/media/85473/download

This guidance states that you do not need to label if the device is not manufactured from latex.

 

[destroyed9218]

Thank you!!