# K182172: Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Apr 24, 2019 after 257 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K080795 (2008). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080795: Ultra Surgical Gown & Fluid Barrier Surgical Gown, Kimberly-Clark Corp. (2008) Summary page 5.

## Most influential descendants
- K252301: Henan Yadu Level 4 Surgical Gowns (Reinforced) (2026), 0 descendants of its own
- K242844: Medline Level 4 Surgical Gown with Breathable Sleeves (2025), 0 descendants of its own

## Recalls of this device
- Nov 29, 2023 · Class II · Z-0711-2024: Surgical gowns were manufactured with the wrong sleeve.

## Indications for use
The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) is a 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 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

Source page: https://510kreport.com/device/K182172
Methodology: https://510kreport.com/methodology