# K973657: Arglaes-AB  Antimicrobial Barrier Island Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Maersk Medical, Ltd.
- Decided: Dec 1, 1997 after 67 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
43 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K990810: Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing (1999), 28 descendants of its own
- K990530: Kerlix MD Antimicrobial Gauze Dressing (2000), 21 descendants of its own
- 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
- K070653: Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662 (2007), 7 descendants of its own
- K061220: Urgotul AG (2006), 7 descendants of its own

## Indications for use
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, for use on individuals with a known sensitivity to silver, and are not intended to be surgically implanted.

Source page: https://510kreport.com/device/K973657
Methodology: https://510kreport.com/methodology