# K033057: Deroyal Surgical Gowns, Sterile, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal
- Decided: Nov 20, 2003 after 52 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 K023117 (2002). 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)
- K023117: Primagard Surgical Gowns, Primeline Medical Products, Inc. (2002)
- (no number) Precept Ultraguard Surgical Gowns: named in the summary without a submission number

## Indications for use
DeRoyal Surgical Gowns are identified in 21 CFR, part 878.4040 as surgical attire to be worn by operating room personnel during surgical procedures to protect both operating room personnel and the patient from the transfer of microorganisms, body fluids and other particulate materials.

Source page: https://510kreport.com/device/K033057
Methodology: https://510kreport.com/methodology