# K260725: BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)

- Pathway: 510(k) (Traditional)
- Applicant: Hindernis DE Mexico, S.A.P.I. DE C.V.
- Decided: May 12, 2026 after 68 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: 6 generations back to K981393 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200522: AERO CHROME* Breathable Performance Surgical Gowns, O&M Halyard, Inc. (2020) Summary page 6.

## Indications for use
BAUMER Surgical Gowns (COP01, COP04, COP0S5, and COP10) are intended to be worn by healthcare professionals to help protect both the patients and the healthcare professionals from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 4 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gowns are single use, disposable, and provided sterile.

Source page: https://510kreport.com/device/K260725
Methodology: https://510kreport.com/methodology