# K061762: Tiburon Drape, Model 9349N/ Optima Drape, Model 9446N

- Pathway: 510(k) (Special)
- Applicant: Cardinal Health, Inc.
- Decided: Aug 1, 2006 after 40 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. The FDA summary names its predicate without a number.
- (no number) Convertors® Trilaminate and Optima drape materials: named in the summary without a submission number

## Indications for use
Convertors® Surgical drapes are made from natural and synthetic materials that are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contaminated. The drape is a single use disposable device intended for repackaging and sterilization before use. This single use product is a disposable non-sterile drape designed to be repackaged and sterilized prior to use. This product maybe sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization and Ethylene Oxide following the Validation and Routine Control under ANSI/AMMI/ISO 11134 & 11135. For more information about sterilization of this product, contact Cardinal Health Inc. The exception for Steam sterilization is that the Trilaminate drapes, Trilaminate and Optima drapes with fluid control pouches, cannot undergo steam sterilization. Steam sterilization may cause the polyethylene in the film layer on the Trilaminate drape and the polyethylene in the fluid control pouch on these drapes to melt. Ethylene oxide is the only method of sterilization for these drapes.

Source page: https://510kreport.com/device/K061762
Methodology: https://510kreport.com/methodology