# K982694: Medline Medcrest Surgical Gowns and Surgical Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Dec 14, 1998 after 133 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 28, 2026 · Class II · Z-1563-2026: Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If dela

## Indications for use
Medline Medcrest Surgical Gowns are surgical apparel that is intended to be wom by operating room personnel during surgical procedures to help 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/K982694
Methodology: https://510kreport.com/methodology