# K202447: Medline Orbis Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Apr 2, 2021 after 219 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Medline Orbis Surgical Gown is a single use, Level 4 surgical gown intended to be worn by healthcare professionals during surgical procedures to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Orbis Surgical Gown meets the Level 4 requirements in accordance with ANSI/AAMIPB70:2012 “Liquid barrier and performance classification of protective apparel and drapes intended for use in healthcare facilities”.

Source page: https://510kreport.com/device/K202447
Methodology: https://510kreport.com/methodology