# K031408: Deroyal Poly-Reinforced Surgical Gowns (Sterile, Non-Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal
- Decided: Oct 15, 2003 after 163 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
DeRoyal Poly-Reinforced Surgical Gowns are surgical attire that is worn by operating room personnel to protect both operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate materials during surgical procedures.

Source page: https://510kreport.com/device/K031408
Methodology: https://510kreport.com/methodology