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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:

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:

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GCI surgical gown is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 2 barrier classification.

GCI Surgical Gowns are intended to be used during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate materials. The gown is available in multiple sizes. They are provided non- sterile and intended to be sterilized prior to use. They are reusable up to 75 uses. Per ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel intended for use in health care facilities, the proposed devices meet the requirements for 2, as indicated by their labeling.

This document describes the non-clinical performance testing of the GCI Surgical Gown to demonstrate its substantial equivalence to a legally marketed predicate device (K211422).

1. Table of Acceptance Criteria and Reported Device Performance

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