# K982058: Rotecno FR (Fluid Resistant) Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Encompass Group, LLC
- Decided: Jan 14, 1999 after 217 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.
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. The FDA summary names its predicate without a number.
- (no number) SafeCare™ Reusable Surgical Gown: named in the summary without a submission number

## Indications for use
Intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K982058
Methodology: https://510kreport.com/methodology