# K023969: Reactive Skin Decontamination Lotion

- Pathway: 510(k) (Traditional)
- Applicant: Dept. of the Army
- Decided: Mar 25, 2003 after 116 days
- Product code: MAC (Decontamination Kit)
- Device class: 1
- Regulation: 21 CFR 878.4014
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894455 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894455: Decontaminating Kit, Skin: M291, Dept. of the Army (1989) Summary page 1.

## Recalls of this device
- Nov 24, 2022 · Class I · Z-0773-2023: Complaints of leaking packets were received.

## Indications for use
The Reactive Skin Decontamination Lotion is intended to remove or neutralize chemical warfare agents and T-2 toxin from the skin.

Source page: https://510kreport.com/device/K023969
Methodology: https://510kreport.com/methodology