# K992514: Convertors Breathable Surgical Gowns

- Pathway: 510(k) (Special)
- Applicant: Allegiance Healthcare Corp.
- Decided: Aug 12, 1999 after 15 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 Gowns: named in the summary without a submission number

## Most influential descendants
- K120045: Emm High Performance Surgical Gown with Aami Liquid Barrier Level IV (2012), 0 descendants of its own

## Indications for use
The Convertors® Breathable 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/K992514
Methodology: https://510kreport.com/methodology