# K112136: Top Drape Sterile, Top Drape-Non Sterile, Bottom Drape- Sterile, Bottom Drape

- Pathway: 510(k) (Traditional)
- Applicant: Kunshan Jiehong Nonwoven Product Co., Ltd.
- Decided: Sep 29, 2011 after 65 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
Disposable sterile drapes are intended for use for: * patient protective covering used to isolate incision sites and protect against contamination during surgical procedures. * cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. These drapes are used protect surgical and non-surgical equipment from contamination during surgical procedures Drapes provided as sterile and non-sterile. Non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 11135.

Source page: https://510kreport.com/device/K112136
Methodology: https://510kreport.com/methodology