# K990395: Barrier Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Div. of Ethicon, Inc.
- Decided: Apr 13, 1999 after 63 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) BARRIER Extra Protection Plus surgical gown: named in the summary without a submission number

## Most influential descendants
- K050786: Barrier Surgical Gowns (2005), 0 descendants of its own

## Indications for use
A BARRIER surgical gown is a single use article of surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K990395
Methodology: https://510kreport.com/methodology