# K102861: Surgiplus SMS Surgical Drape (Sterile/Non-Sterile), Surgiplus SPP with PE Laminated Surgical Drape (Sterile/Non-Sterile)

- Pathway: 510(k) (Traditional)
- Applicant: A Plus International, Inc.
- Decided: Jan 13, 2011 after 105 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
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Surgilus Surgical Drapes are single use, disposable patient coverings intended to be used by operating room personnel during surgical and other medical procedures as protective covers to isolate surgical incision sites from microbial and other contaminations. Below please find the device names, model numbers and total number of surgical drapes for this submission. The Surgilus Surgical Drapes are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization. The drapes are classified as Level 3 or Level 4 per AAMI Standard PB7O Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Source page: https://510kreport.com/device/K102861
Methodology: https://510kreport.com/methodology