Dukal Crepe Paper Sterilization Wrap

Dukal Crepe Paper Sterilization Wrap is an FDA 510(k)-cleared medical device (K252823) manufactured by Dukal, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 27, 2026. Regulation: 8.