# K944393: Stryker Steri-Shield Surgical Apparel

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Aug 28, 1995 after 353 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## 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

## Recalls of this device
- Jun 1, 2012 · Class II · Z-1809-2012: The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing pr
- Jun 1, 2012 · Class II · Z-1810-2012: The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing p

Source page: https://510kreport.com/device/K944393
Methodology: https://510kreport.com/methodology