# K030364: Deroyal Gowns, Sterile, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Apr 28, 2003 after 83 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.
26 later devices descend from it; 1 cites it directly.
0 of 27 devices 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.

## Most influential descendants
- K052550: Imc Surgical Gowns (2005), 25 descendants of its own
- K100971: Atek Surgical Gowns (2010), 21 descendants of its own
- K120192: Disposable Surgical Gowns (2012), 20 descendants of its own
- K172987: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) (2018), 19 descendants of its own
- K211422: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown (2021), 11 descendants of its own

## Indications for use
DeRoyal 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. DeRoyal will receive the nonsterile gowns from the converter made to DeRoyal's specification and use them in Convenience Kits that are sterilized, market the nonsterile gowns to other OEM customers, and market sterile individually packaged gowns.

Source page: https://510kreport.com/device/K030364
Methodology: https://510kreport.com/methodology