# K063005: Stryker T6 Hoods and Togas

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Mar 23, 2007 after 172 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: 2 generations back to K944393 (1995). 4 ancestors in all.
3 later devices descend from it; 2 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)
- K040764: Stryker T4 Hytrel Zipper Toga, Stryker Corp. (2004) Summary page 1.
- K023167: Breathable Surgical Gown, Allegiance Healthcare Corp. (2002) Summary page 1.

## Most influential descendants
- 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 T6 Hood; T6 Hood, Peel-away; T6 Hood, S95; T6 Toga, Pullover; T6 Toga, Zippered; and T6 Toga with Peel-away Lens, Zippered are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

Source page: https://510kreport.com/device/K063005
Methodology: https://510kreport.com/methodology