# K203539: Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)

- Pathway: 510(k) (Traditional)
- Applicant: Unicoglobal, Inc.
- Decided: Dec 10, 2021 after 372 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: 3 generations back to K020593 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190950: Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced), Medline Industries, Inc. (2019) Summary page 4.

## Indications for use
The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The Unico Global Level 3 Surgical Gowns meets the respective level requirements of ANSI/AAMI PB70:2012 level 3 liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are single use, disposable medical devices; provided sterile or non-sterile. 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 users after EtO sterilization validation to ISO 11135-1.

Source page: https://510kreport.com/device/K203539
Methodology: https://510kreport.com/methodology