# K013846: Ultragard Impervious Reinforced Gown

- Pathway: 510(k) (Traditional)
- Applicant: Precept Medical Products, Inc.
- Decided: May 22, 2002 after 183 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 K842115 (1984). 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)
- K842115: Spungard & Surg. Drapes-Gowns & Packs, Kimberly-Clark Corp. (1984) Summary page 1.

## Indications for use
UltraGard™ Blue O. R. Gown with Impervious Reinforced Chest and Sleeves is indicated for use in operating room procedures as a sterile cover garment.

Source page: https://510kreport.com/device/K013846
Methodology: https://510kreport.com/methodology