# K251860: Copioumed AAMI 3 Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Copioumed International, Inc.
- Decided: Feb 26, 2026 after 254 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
Longest line of descent: 2 generations back to K020593 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170762: Cardinal Health Non-Reinforced Surgical Gown, Cardinal Health200, LLC (2017) Summary page 6.

## Indications for use
Copioumed AAMI 3 Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect both surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate materials. The gown is single-use, disposable, and provided sterile, and is classified as AAMI Level 3.

Source page: https://510kreport.com/device/K251860
Methodology: https://510kreport.com/methodology