# K120930: CHG Antibacterial Foam Dressing, CHG Antibacterial Patch, CHG Antibacterial Foam Patch, CHG Patch, CHG Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Medtrade Products, Ltd.
- Decided: Oct 26, 2012 after 213 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: 2 generations back to K895920 (1991). 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)
- K003229: Biopatch Antimicrobial Dressing, Integra Lifesciences Corp. (2001) Summary page 1.

## Indications for use
Under the supervision of a healthcare professional CHG Antibacterial Foam Patch is intended for use as: A hydrophilic foam patch that is used to absorb exudates and to cover the peni-wound area of a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, midline catheters, drains, chest tubes, externally placed orthopaedic pins, and epidural catheters.

Source page: https://510kreport.com/device/K120930
Methodology: https://510kreport.com/methodology