# K022162: Stryker T4 Urethane Hood; Stryker T4 Urethane Zipper Toga; Stryker T4 Urethane Pullover Toga

- Pathway: 510(k) (Special)
- Applicant: Stryker Instruments
- Decided: Aug 1, 2002 after 29 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: 1 generation back to K944393 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944393: Stryker Steri-Shield Surgical Apparel, Stryker Corp. (1995) Summary page 1.
- K993148: Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover Toga, Stryker Instruments (1999) Summary page 1.
- K011755: Stryker T4 Hytrel (R) Togas, Stryker Corp. (2001)

## Indications for use
The Stryker T4 Urethane Hood, Zippered Toga, and Pullover 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/K022162
Methodology: https://510kreport.com/methodology