# K221110: LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Jan 4, 2024 after 629 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- 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 K914604 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210718: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing, Huizhou Foryou Medical Devices Co., Ltd. (2022) Summary page 4.

## Indications for use
Under the supervision of a healthcare professional: LUOFUCON® Silver Gelling Fiber Surgical Dressing may be used for the management of surgical wounds as an effective barrier to microbial penetration of the dressing. OTC use: LUOFUCON® Antibacterial Gelling Fiber Cover Dressing may be used for: Minor abrasions; Minor lacerations; Minor cuts; Minor scalds and burns.

Source page: https://510kreport.com/device/K221110
Methodology: https://510kreport.com/methodology