Natural Rubber Latex, Whether or Not Prevulcanized

Prevulcanized latex has undergone heat treatment that cross-links the polymer chains, allowing manufacturers to dip finished goods directly without additional vulcanization steps. Unvulcanized field latex requires compounding and vulcanization at the manufacturing facility. The distinction affects price, shelf life, and the downstream processing equipment required, so buyers should specify vulcanization state precisely in purchase contracts.

Yes. Natural rubber latex used in medical devices — such as surgical gloves or catheters — falls under FDA jurisdiction. FDA has issued guidance on latex allergen labeling, and manufacturers importing latex for medical-device production must ensure their supply chain meets applicable device regulations. Importers should consult FDA guidance and, where appropriate, a licensed customs broker familiar with medical-device entry requirements.