# K970566: Arglaes Film Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Maersk Medical, Ltd.
- Decided: Jul 29, 1997 after 166 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
No predicates in its family tree.
177 later devices descend from it; 5 cite it directly.
0 of 178 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
- K981299: Silverlon Contact Wound Dressing (1998), 149 descendants of its own
- K023612: Silverlon Contact Wound Dressing (2003), 102 descendants of its own
- K063069: Silvaklenz Skin and Wound Clenser Solution (2007), 73 descendants of its own
- K073547: Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound Gel (2008), 66 descendants of its own
- K090206: Oculus Puracyn Antimicrobial Skin and Wound Cleanser (2009), 37 descendants of its own

## Indications for use
ARGLAES 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 Film Dressings are also intended to help secure and protect intravenous catheters.

Source page: https://510kreport.com/device/K970566
Methodology: https://510kreport.com/methodology