# K012984: Breathable Impervious Gowns

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corp.
- Decided: Sep 24, 2001 after 18 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K150151: SmartGownTM surgical gown (2015), 0 descendants of its own

## 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/K012984
Methodology: https://510kreport.com/methodology