# K023167: Breathable Surgical Gown

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corp.
- Decided: Oct 2, 2002 after 9 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Convertors® Breathable Surgical Gowns: named in the summary without a submission number

## Most influential descendants
- 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
- Nov 2, 2021 · Class II · Z-0369-2022: Potential for open packaging seals compromising the sterility of the surgical gowns
- Nov 2, 2021 · Class II · Z-0370-2022: Potential for open packaging seals compromising the sterility of the surgical gowns
- Nov 2, 2021 · Class II · Z-0371-2022: Potential for open packaging seals compromising the sterility of the surgical gowns

## Indications for use
The Convertors® Breathable Surgical Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K023167
Methodology: https://510kreport.com/methodology