# K121664: T4/T5 Hytrel Togas

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Mar 10, 2014 after 643 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
The Stryker T4/T5 H-ytrel Toga is intended to provide a barrier between the operating environment and members of the surgical team in order to help protect against contamination and/or exposure of infetious body fluids and harmfl miicroorganisms. The iT4 and T5 Hytrel Togas are sterile, single Use oily.

Source page: https://510kreport.com/device/K121664
Methodology: https://510kreport.com/methodology