# K220333: Medline Orbis LVL 3 Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: May 18, 2022 after 103 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 LVL 3 Surgical Gown is 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 LVL 3 Surgical Gown is a single use, disposable medical device provided both sterile and non-sterile. The Medline Orbis LVL 3 Surgical Gown meets the Level 3 requirements of ANSI/AAMIPB70:2012 Liquid barrier and performance classification of protective apparel and drapes intended for use in healthcare facilities. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.

Source page: https://510kreport.com/device/K220333
Methodology: https://510kreport.com/methodology