A Surgical Gown is regulated by the FDA as a Class II medical device that requires a 510(K) Premarket notification.
Surgical Sterilized Gown
Made with SMS material, Cuff Sleeve.
Certificates: FDA & CE
All Test reports will be sent once customer is serious and ready to proceed.
Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2
Two tests are conducted to test barrier protection performance:
Water impacting the surface of the gown material and Pressurizing the material.