# K050786: Barrier Surgical Gowns

- Pathway: 510(k) (Special)
- Applicant: Molnlycke Health Care
- Decided: May 9, 2005 after 42 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
Longest line of descent: 1 generation back to K760903 (1976). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760903: Barrier Fabric 450 Surgical Gowns, Surgikos, Inc. (1976) Summary page 2.
- K932731: Barrier* Extra Protection Plus Surgical Gown, Johnson & Johnson Medical, Inc. (1994) Summary page 2.
- K920996: Barrier Surgical Gown with Symetry Fabric, Johnson & Johnson Medical, Inc. (1992) Summary page 2.
- K990395: Barrier Surgical Gowns, Johnson & Johnson Medical, Div. of Ethicon, Inc. (1999) Summary page 2.

## Indications for use
BARRIER® surgical gowns are intended for single use to be worn by the Surgical Team Members in the operating room during surgical procedures to protect both the patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K050786
Methodology: https://510kreport.com/methodology