# K111458: Gri Sterile and Non-Sterile Surgical Drapes and Surgical Equipment Covers

- Pathway: 510(k) (Traditional)
- Applicant: Gri Medical & Electronic Technology Co., Ltd.
- Decided: Dec 1, 2011 after 189 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
Longest line of descent: 2 generations back to K080629 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083234: Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical Equipment Covers, Model KC 100, Kimberly-Clark Corp. (2009) Summary page 2.

## Indications for use
GRI single use drapes (both sterile and non-sterile) are made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. Non-sterile GRI surgical drapes are sold in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization. The drapes are classified as level 3 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities. GRI single use surgical equipment covers (both sterile and non-sterile) are protective barrier covers intended to be used to cover surgical equipment and provide a protective barrier for that equipment. Non-sterile GRI surgical equipment covers are sold in bulk as single use items, to repackager/ relabeler establishments for further packaging and ethylene oxide (EtO) sterilization. The covers are classified as level 3 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in health-care facilities.

Source page: https://510kreport.com/device/K111458
Methodology: https://510kreport.com/methodology