# K011755: Stryker T4 Hytrel (R) Togas

- Pathway: 510(k) (Special)
- Applicant: Stryker Corp.
- Decided: Jun 22, 2001 after 16 days
- Product code: LYU (Accessory, Surgical Apparel)
- Device class: 1
- 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K040764: Stryker T4 Hytrel Zipper Toga (2004), 5 descendants of its own
- K063005: Stryker T6 Hoods and Togas (2007), 3 descendants of its own
- K073017: Stryker Stri-Shield Flyte Togas (2007), 1 descendant of its own
- K141095: Stryker Steri-Shield Flyte Hybrid Togas (2014), 0 descendants of its own
- K140588: Flyte Hybrid Hood, Flyte Hybrid Hood with Peelaway Lens (2014), 0 descendants of its own

## Indications for use
The Stryker Hytrel® Zippered Toga and Pull-over Toga are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Source page: https://510kreport.com/device/K011755
Methodology: https://510kreport.com/methodology