# K982693: Medine Disposable Sterile Zoned Impervious Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Oct 28, 1998 after 86 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 K934608 (1994). 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)
- K934608: Barrier Fabric 450 Surgical Gown, Johnson & Johnson Medical, Inc. (1994) Summary page 1.

## Indications for use
Medline Disposable Sterile Surgical Gowns, Zoned Impervious are surgical apparel that is 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/K982693
Methodology: https://510kreport.com/methodology