(122 days)
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 | 1 lbs |
| P82424 KBRO | 24"x24" | Pink | 1.82 lbs |
| P83030 KBRO | 30"x30" | Yellow | 3.45 lbs |
| P83636 KBRO | 36"x36" | Blue | 5.8 lbs |
| P84545 KBRO | 45"x45" | Mint | 10.98 lbs |
| P85454 KBRO | 54"x54" | Red | 18.5 lbs |
| 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.
GCI Sterilization Wrappers are intended to enclose a textile-based medical device for sterilization and maintain sterility of the enclosed device until used.
The proposed devices are medical devices that are provided non-sterile. They may be reused up to 38 times. They are available in multiple sizes to accommodate textile-based medical devices, ranging from 18"x18" to 60"x60". The size is indicated by color coding of the wrap borders for easy identification.
Load sizes should be large enough to prevent too much overlapping of the wrapper material (such that all but one side of the wrapper should be a single layer when properly folded) to allow appropriate sterilant penetration. Load sizes should be small enough to overlap by at least 2 inches on the remaining side to ensure there are no gaps.
This document pertains to the 510(k) clearance for GCI Sterilization Wrappers, a Class II medical device. The information provided outlines the non-clinical performance data used to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria | Reported Device Performance (GCI Sterilization Wrappers) |
|---|---|---|
| Tearing Strength (ASTM D5587) | >20 PSI Standard fabric direction | > 21 PSI Standard fabric direction |
| Breaking Strength (ASTM D5034) | >20 PSI | > 163 PSI |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
| Water Resistance: Hydrostatic Pressure (AATCC 127) | Water Resistant, >20 cm H2O | Water Resistant, >27 cm H2O |
| Water Resistance: Impact Penetration (AATCC 42) |
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).