# K842115: Spungard & Surg. Drapes-Gowns & Packs

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Jun 11, 1984 after 47 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K042893: Under Buttocks Drape (2005), 0 descendants of its own
- K013846: Ultragard Impervious Reinforced Gown (2002), 0 descendants of its own

## Recalls of this device
- Jul 5, 2012 · Class II · Z-0257-2013: Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

Source page: https://510kreport.com/device/K842115
Methodology: https://510kreport.com/methodology