# K262007: PRIMED AAMI Level 3 Open Back Gowns

- Pathway: 510(k) (Traditional)
- Applicant: PRIMED Medical Products, Inc.
- Decided: Sep 11, 2026 after 88 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: 4 generations back to K925077 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233526: Medline Open-back Level 3 Protective Gown, Medline Industries, LP (2024) Summary page 6.

## Indications for use
PRIMED AAMI Level 3 Open Back Gowns are non-sterile, single use gowns intended to be worn by healthcare personnel to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material in non-surgical, non-isolation settings.

Source page: https://510kreport.com/device/K262007
Methodology: https://510kreport.com/methodology