# K200977: Modular Toga

- Pathway: 510(k) (Traditional)
- Applicant: Operating Room Innovations, Inc.
- Decided: Aug 5, 2020 after 114 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Operating Room Innovation's Modular Toga are components of a personal protection system and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

Source page: https://510kreport.com/device/K200977
Methodology: https://510kreport.com/methodology