# K141095: Stryker Steri-Shield Flyte Hybrid Togas

- Pathway: 510(k) (Special)
- Applicant: Stryker Corporation
- Decided: Aug 26, 2014 after 120 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
Longest line of descent: 4 generations back to K944393 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073017: Stryker Stri-Shield Flyte Togas, Stryker Instruments, Instruments Div. (2007) Summary page 5.

## Indications for use
The Stryker Steri-Shield Flyte Hybrid Togas 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. The togas are sterile and single use only.

Source page: https://510kreport.com/device/K141095
Methodology: https://510kreport.com/methodology