# K023635: Sri/Surgical Express SP Reusable Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Sri/Surgical Express, Inc.
- Decided: Nov 18, 2002 after 20 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 K920405 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920405: Sterile Surgeon's Gown, Amsco Sterile Recoveries, Inc. (1992) Summary page 1.

## Indications for use
Surgical gowns are devices that are intended to be worn by health care personnel during surgical or other medical procedures to protect both the surgical patient and the wearer from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K023635
Methodology: https://510kreport.com/methodology