# K200493: Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Mar 21, 2020 after 22 days
- Product code: FXY (Hood, 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K241272: Stryker Steri-Shield 8 Surgical Hoods and Togas (2024), 0 descendants of its own

## Indications for use
The Stryker T7 Togas and Stryker T7 Hoods are components of Stryker T7 Personal Protective Equipment (PPE). These surgical devices are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker T7 Togas and Stryker T7 Hoods are sterile, single use only devices.

Source page: https://510kreport.com/device/K200493
Methodology: https://510kreport.com/methodology