# K102666: Kimberly-Clark Surgical Drapes with Aami Liquid Barrier Level 4 Claim

- Pathway: 510(k) (Abbreviated)
- Applicant: Kimberly-Clark Corp.
- Decided: Nov 9, 2010 after 55 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- 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: 2 generations back to K080629 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083234: Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical Equipment Covers, Model KC 100, Kimberly-Clark Corp. (2009) Summary page 1.

## Most influential descendants
- K121919: Surgical Drape with Aami Liquid Barrier Level IV (2013), 0 descendants of its own

## Indications for use
Kimberly-Clark* Corporation intends to market the sterile Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim as devices made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim meet the Level 4 requirements of the AAMI Liquid Barrier classifications. The Kimberly-Clark* Surgical Drapes with AAMI Liquid Barrier Level 4 claim are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

Source page: https://510kreport.com/device/K102666
Methodology: https://510kreport.com/methodology