# K992445: Med-Guard Surgeon's Gown

- Pathway: 510(k) (Traditional)
- Applicant: Kappler USA
- Decided: Feb 18, 2000 after 211 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 K781682 (1978). 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)
- K781682: Surgical Gowns & Drapes, Kimberly-Clark Corp. (1978) Summary page 1.

## Indications for use
The surgical gown is intended to protect the wearer from blood and other body fluids encountered during surgery.

Source page: https://510kreport.com/device/K992445
Methodology: https://510kreport.com/methodology