# K233151: PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Mar 26, 2024 after 181 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: 5 generations back to K961758 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110172: Sonafine Wound Dressing, Stratus Pharmaceutical (2011) Summary page 4.

## Indications for use
Rx Indications for Use: PluroGel® Antimicrobial Burn and Wound Dressing is indicated for the management of full and partial thickness wounds including surgically created wounds, dermal ulcers (pressure ulcers), leg ulcers (diabetic foot ulcers), superficial wounds, first degree burns, partial thickness burns, and donor sites. PluroGel® Antimicrobial Burn and Wound Dressing maintains a moist wound and skin environment that supports autolytic debridement of necrotic tissue. OTC Indications for Use: PluroGel® Burn and Wound Dressing (OTC) is indicated for the management of minor cuts, minor burns, and minor lacerations. PluroGel® Burn and Wound Dressing (OTC) maintains a moist wound and skin environment.

Source page: https://510kreport.com/device/K233151
Methodology: https://510kreport.com/methodology