Best Seal Surgical Drapes meet the following FDA Standards

  • FDA 510(k) Premarket Notification
  • K121919 ISO 10993 Biocompatible
  • K120045 ISO 11135 Sterilization Validation
  • K111535 ISO 11607 Packaging for Terminally Sterilized Medical Devices
  • K101598 AAMI PB:70 Liquid Barrier Compliant
  • K101688 EN13795 Barrier Compliant (Standard/High Performance)
  • K101689 16CFR1610:2007 – Compliant Flammability Rating
  • K101593 FDA Premarket Notification meets the AAMI PB:70 Level 1 through 4 standards for Gowns and Drapes

Our drape material is a medical SMS fabric made of polypropylene. This is unique trilaminate (Spun-bound, Melt-blown, Spun-bound) construction that offers a high tensile strength and toughness that is also soft, drapable, and easy to work with. This Non-Woven SMS fabric material provides a fluid and particulate barrier to protect the worker without sacrificing mobility and comfort. Drapes and Gowns constructed of SMS fabric are strong and durable, and offer outstanding comfort, breathability, softness, and wearability. It is lightweight and resistant to tears and punctures