# K980863: Dumex Pak-Its Non-Woven Dressing Impregnated Sith Sodium Chloride (Hypertonic)

- Pathway: 510(k) (Traditional)
- Applicant: Dumex Medical Surgical Products, Ltd.
- Decided: May 11, 1998 after 67 days
- Product code: KMF (Bandage, Liquid)
- Device class: 1
- Regulation: 21 CFR 880.5090
- 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
Non-Woven dressing impregnated with Sodium Chioride is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to the wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications:minor cuts, minor bumms and minor lacerations. Under the guidance of a health care professional, "AbsorbaSalt" Cotton Gauze Packing is also indicated for sumlcal Incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.

Source page: https://510kreport.com/device/K980863
Methodology: https://510kreport.com/methodology