# K030908: Deroyal Surgical Drapes Backtable Cover

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal
- Decided: Aug 11, 2003 after 140 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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 Back Table Covers are intended to provide a sterile surface for a surgical operating room back table that becomes part of the sterile field. DeRoyal’s Back Table Covers will provide protection against contamination during surgical procedures. DeRoyal will receive the nonsterile back table covers from a converter made to DeRoyal’s specifications. DeRoyal will use them to wrap convenience kits that will be sterilized in a header pouch. When the convenience kit is removed out of the header pouch it will be used as a surgical drape for the surgical operating room back table. DeRoyal will market nonsterile sterilization wrap to other OEM customers.

Source page: https://510kreport.com/device/K030908
Methodology: https://510kreport.com/methodology