Collection: Aegis Wrap's FDA Clearance

The Aegis Wrap is a FDA cleared General Wellness (C#170068) skin-to-skin wrap that can be used in all settings of the hospital: Operating Room, PACU, Postpartum, Mom-Baby, and NICU. 

Hospital Policy states that everything from scalpels to baby blankets must be FDA cleared to be used in the Operating Room. 

Some skin-to-skin products/wraps say or imply that they are FDA Cleared and can be used in the Operating Room; however this can impose a major safety to patients and federal compliance risk to hospitals.

The Aegis Wrap went through extensive testing and FDA General Wellness Clearance to ensure the highest level of safety without putting newborns and mamas at risk.