What is the DNR manufacturing process?
The DNR manufacturing process involves the use of coagulated natural latex in the form of dried or milled sheets. Products are formed from dry natural rubber by compression molding, extrusion, or by converting the sheets into a solution for dipping. These products are typically referred to as containing or made of dry natural rubber or “crepe” rubber. Examples of products that may contain dry natural rubber include syringe plungers, vial stoppers, and injection ports on intravascular tubing. • What does the phrase “contains natural rubber” mean in this rule? A device “contains natural rubber,” for the purposes of this rule, when the device is composed of natural rubber or the device contains components formulate from natural rubber. The phrase, “contains natural rubber,” as used herein, also includes products described as made of “synthetic latex” or “synthetic rubber” that include natural rubber in their formulations. Synthetic latex or synthetic rubber that does not include natural
