# K043585: Medline Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Mar 8, 2005 after 70 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.
20 later devices descend from it; 1 cites it directly.
0 of 21 devices 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.

## Most influential descendants
- K172987: Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) (2018), 19 descendants of its own
- K211422: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown (2021), 11 descendants of its own
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown (2021), 3 descendants of its own
- K212861: Surgical Gown, Reinforced Surgical Gown (2021), 2 descendants of its own
- K202844: Medical Surgical Gowns (2021), 2 descendants of its own

## Indications for use
Medline Disposable EclipseTM Surgical Gowns are surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of body fluids, micro-organisms, and particulate material.

Source page: https://510kreport.com/device/K043585
Methodology: https://510kreport.com/methodology