# K051426: Carlo Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Sofilm Technology Co., Ltd.
- Decided: Aug 2, 2005 after 62 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Sofilm Technology Co., Ltd. Carlo Surgical Gown is a sterile, single-use surgical gown that is 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 microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K051426
Methodology: https://510kreport.com/methodology