# K250321: GCI Sterilization Wrappers

- Pathway: 510(k) (Traditional)
- Applicant: George Courey, Inc.
- Decided: Jun 6, 2025 after 122 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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 K923408 (1993). 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)
- K172207: Standard Supreme Sterilization Wrapper, Standard Textile Co., Inc. (2017) Summary page 5.

## Indications for use
GCI Sterilization Wrappers are intended to be used to enclose reusable textile-based medical devices, such as surgical gowns, towels, and drapes, for sterilization by a health care provider. They are designed to allow effective steam sterilization of the enclosed textile items and to maintain sterility until use, for up to 28 days. GCI Sterilization Wrapper sizes and validated load limitations are as follows: SKU / Model Size Border Color Maximum Validated Load Weight P81818 KBRO 18”x18” White 1lbs P82424 KBRO 24"x24” Pink 1.82 Ibs P83030 KBRO 30”x30” Yellow 3.45Ibs P83636 KBRO 36”x36” Blue 5.8 Ibs P84545 KBRO 45"x45" Mint 10.98 Ibs P85454 KBRO 54”x54” Red 18.5 Ibs P86060 KBRO 60”x60” Green 25 lbs GCI Sterilization Wrappers are reusable through 38 wash, dry, and sterilization cycles. Pack assembly should follow established folding, assembly, and wrapping procedures as defined by the clinical staff for aseptic presentation of the pack and its contents. Closure can include autoclave tape and elastomer closures. Sterilization: A prevacuum steam sterilization cycle (4 minutes exposure at 132°C, Dry Time: 30 minutes) has been validated.

Source page: https://510kreport.com/device/K250321
Methodology: https://510kreport.com/methodology