# K111067: Jie+Hong Medical Surgical Gowns - Sterile, Jie+Hong Medical Surgical Gowns - Non Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Kunshan Jiehong Nonwoven Product Co., Ltd.
- Decided: Aug 2, 2011 after 106 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material. Gowns are provided as sterile and non-sterile. Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtC cycle validated to ISO 11135 standard.

Source page: https://510kreport.com/device/K111067
Methodology: https://510kreport.com/methodology