# K990810: Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Maersk Medical, Ltd.
- Decided: Sep 17, 1999 after 190 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: 1 generation back to K970566 (1997). 2 ancestors in all.
28 later devices descend from it; 8 cite it directly.
0 of 31 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 2.
- K973657: Arglaes-AB  Antimicrobial Barrier Island Dressing, Maersk Medical, Ltd. (1997) Summary page 2.

## Most influential descendants
- K013525: Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) (2002), 13 descendants of its own
- K061220: Urgotul AG (2006), 7 descendants of its own
- K024054: Xylos Xcell Antimicrobial Dressing (2003), 7 descendants of its own
- K062559: Urgocell AG Antimicrobial Wound Dressing with Silver (2007), 6 descendants of its own
- K121819: Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver (2012), 3 descendants of its own

## Indications for use
ARGLAES-AB Antimicrobial Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers. ARGLAES-AB Antimicrobial Film Dressings are also intended to help secure and protect intravenous catheters. ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressings composed of a calcium alginate pad presented on a visually clear, self-adherent, antimicrobial barrier film backing. ARGLAES-AB Antimicrobial Barrier Island Dressings are intended for the local management of exuding wounds, including infected and non-infected: Pressure Ulcers Venous Ulcers Diabetic Ulcers Arterial Ulcers Donor Sites and other bleeding surface wounds Dermal lesions, trauma injuries or incisions. ARGLAES-AB Antimicrobial Barrier Island Dressings are contraindicated for third degree burns or for use on individuals with a known sensitivity to silver.

Source page: https://510kreport.com/device/K990810
Methodology: https://510kreport.com/methodology