# K991755: Medline Tender Wet Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Apr 17, 2000 after 329 days
- Product code: MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Medline TenderWet™ is a multi-layer wound dressing pad whose central component is a super-absorbent polymer (SAP). This product maintains a moist wound environment that supports the healing process by encouraging autolytic debridement and allowing granulation to proceed under optimum conditions. It protects against dehydration, bacterial contamination, and absorbs exudate from the wound. It is indicated for use on dry, light and moderately exuding partial and full thickness wounds such as: First and second degree burns, superficial injuries, lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears. Medline TenderWet™ should be used under direction of a healith care professional for Stage I-1V Pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology. Medline TenderWet™ may be used to condition wound sites prior to skin transplants.

Source page: https://510kreport.com/device/K991755
Methodology: https://510kreport.com/methodology