# K004028: Arglaes-AB Antimicrobial Barrier Powder Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Maersk Medical, Ltd.
- Decided: Mar 27, 2001 after 90 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 K970566 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970566: Arglaes Film Dressing, Maersk Medical, Ltd. (1997) Summary page 5.
- K990810: Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing, Maersk Medical, Ltd. (1999) Summary page 5.
- K973657: Arglaes-AB  Antimicrobial Barrier Island Dressing, Maersk Medical, Ltd. (1997) Summary page 5.
- K881854: Sorbsan Topical Wound Dressing, E.G. Dick & Assoc. (1988) Summary page 5.
- K914575: Sorbsan Topical Wound Dressing (Modified), Dow B. Hickam, Inc. (1991) Summary page 5.

## Indications for use
A topical wound dressing for the treatment of difficult to dress wounds, surface wounds, exudating wounds, including: pressure ulcers, venous ulcers diabetic ulcers arterial ulcers donor sites dermal lesions trauma injuries incisions Laboratory studies for Arglaes AB wound powder have shown the product to resist bacterial penetration through the dressing which may help minimize the risk of infection'. This effect may be limited based upon evenness of application and contact with the wound surface. 'This effect has not been demonstrated clinically at this time.

Source page: https://510kreport.com/device/K004028
Methodology: https://510kreport.com/methodology