# K082479: Sklar Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Sklar Corp.
- Decided: Apr 24, 2009 after 239 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: 3 generations back to K030364 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070431: Welmed, Inc. Surgical Gowns, Welmed, Inc. (2007) Summary page 1.

## Indications for use
The Sklar Surgical Gown is a disposable item that is intended to be used in the operating room as a protective covering, for operating room staff, from the transfer of body fluids and particulates. The Sklar Surgical Gown is provided as sterile and non-sterile. Sterile gowns are to be sold directly to users following EtO sterilization validation according to ISO 11135-1:2007. Non-sterile gowns are to be sold to OEMs for EtO sterilization according to ISO 11135-1:2007.

Source page: https://510kreport.com/device/K082479
Methodology: https://510kreport.com/methodology