# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jul 4, 2019 after 84 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020593 (2002). 2 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020593: Convertors SMS Polyolefin Gown, Allegiance Healthcare Corp. (2002) Summary page 5.
- K170762: Cardinal Health Non-Reinforced Surgical Gown, Cardinal Health200, LLC (2017) Summary page 5.

## Most influential descendants
- K261028: Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) (2026), 0 descendants of its own
- K250564: Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) (2025), 0 descendants of its own
- K220435: SEJONG Surgical Gown Soft (2023), 0 descendants of its own
- K203548: EndoArmor™ + Surgical Gown (2022), 0 descendants of its own
- K203539: Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) (2021), 0 descendants of its own

## Recalls of this device
- Jan 7, 2026 · Class II · Z-1424-2026: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however,
- Jan 7, 2026 · Class II · Z-2129-2026: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however,

## Indications for use
The Medline Level 2 Surgical Gown (Eclipse Non Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced & Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) 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 Medline Level 2 Surgical Gown and the Medline Level 3 Surgical Gowns meet the respective level requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. The Medline Level 2 Surgical Gown and the Medline Level 3 Surgical Gowns have been validated using an ethylene oxide (EtO) sterilization process. The Medline Level 2 Surgical Gown and the Medline Level 3 Surgical Gowns are also sold as bulk single-use, non-sterile, to repackager/relabeler establishments for further packaging and sterilization using the validated EtO sterilization method according to ISO 11135-1 prior to being provided to the end user.

Source page: https://510kreport.com/device/K190950
Methodology: https://510kreport.com/methodology