# K862801: Spunguard Plus Surgical Drape

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Aug 7, 1986 after 15 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.
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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 9, 2016 · Class II · Z-0724-2017: Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site.

Source page: https://510kreport.com/device/K862801
Methodology: https://510kreport.com/methodology