# K993148: Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover Toga

- Pathway: 510(k) (Special)
- Applicant: Stryker Instruments
- Decided: Oct 15, 1999 after 24 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K040485: Maxair Surgical Helmet System (2004), 0 descendants of its own
- K022162: Stryker T4 Urethane Hood; Stryker T4 Urethane Zipper Toga; Stryker T4 Urethane Pullover Toga (2002), 0 descendants of its own

## Indications for use
The Stryker T4 Hood, 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/K993148
Methodology: https://510kreport.com/methodology