Description

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.