# K160471: Medline Non-Surgical Isolation Gown-

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jan 31, 2017 after 347 days
- Product code: FYC (Gown, Isolation, 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Medline Isolation Gown is a single use, non-surgical apparel intended to be worn by healthcare professionals to protect both the patient and the healthcare professionals from the transfer of micro-organisms, body fluids, and particulate matter. The Medline Isolation Gown meets AAMI PB70 Level 3

Source page: https://510kreport.com/device/K160471
Methodology: https://510kreport.com/methodology