# K233526: Medline Open-back Level 3 Protective Gown

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Mar 5, 2024 after 125 days
- Product code: QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection)
- 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 K925077 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210405: ProTEC-USA EZDoff Gown, Cadillac Products, Inc. (2021) Summary page 5.

## Most influential descendants
- K262007: PRIMED AAMI Level 3 Open Back Gowns (2026), 0 descendants of its own

## Indications for use
Gown is a single use, disposable, non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate barrier protection (AAMI Level 3) in non-sterile and non-patient isolation situations.

Source page: https://510kreport.com/device/K233526
Methodology: https://510kreport.com/methodology