# K052870: Integuseal Microbial Sealant, Model IS 100 and 1S200

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Sep 29, 2006 after 353 days
- Product code: NZP (Sealant, Microbial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000442 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000442: Acti-Gard Antimicrobial Film, Models D6635, D6640, D6648, D6650,D6651, D66XX, Medical Concepts Development, Inc. (2001) Summary page 1.

## Indications for use
Integuseal Microbial Sealant is intended for use after typical preoperative skin preparations, with standard surgical draping, and prior to a surgical incision. The product is used to reduce the risk of skin flora contamination throughout a surgical procedure.

Source page: https://510kreport.com/device/K052870
Methodology: https://510kreport.com/methodology