Trinity Guardion Gains 510(k) Clearance for Soteria Bed Barrier

The FDA has granted Batesville, Ind.-headquartered Trinity Guardion 510(k) clearance for its Soteria bed barrier for use on acute and long-term care beds and stretchers.

The reusable device, which provides a barrier to protect the bed and mattress from contamination, is more than a mattress cover, according to the company.

Soteria features a proprietary surface formulation that allows for high-level disinfection and spore removal during laundering — validated for 150 laundry cycles.

The bed barrier also includes a radiofrequency identification (RFID) chip and a barcode to enable tracking of laundry cycles and inventory management.