Description

KIMGUARD HH 300 Sterile Wrap, part of the Kimtech™ Kimguard™ product line by HALYARD, is a high-performance sterilization solution designed for healthcare and sterile processing environments. Its primary function is to enclose medical devices and instrument packages, ensuring their sterility during and after the sterilization process.

Material Composition

Crafted from low-lint SMS (Spunbond-Meltblown-Spunbond) polypropylene, this wrap features a robust four- or five-layer construction. The material includes minimal amounts of phthalocyanine blue pigment, titanium dioxide pigment, and a trace of potassium phosphate for anti-static treatment. It is classified under plastic recycling code 5.

Barrier and Protection

The wrap offers exceptional barrier protection with high bacterial filtration efficiency (BFE) ranging from 96.2% to 99.9%. Enhanced by POWERGUARD Technology, it effectively captures and retains microbes through electric micro-fields. The material is resistant to water, microbial penetration, tears, punctures, abrasion, and ignition, while maintaining low linting. It holds a Class 1 flammability rating and complies with FDA requirements for maintaining package integrity.

Sterilization Compatibility

KIMGUARD HH 300 is compatible with pre-vacuum steam, ethylene oxide (EO), and plasma sterilization methods, such as Sterrad and Steris V-PRO. It facilitates the penetration of gas sterilants and air passage, though it is not suitable for gravity steam, dry heat, or radiation sterilization.

Recommended Use

This wrap is ideal for light to moderate weight packages, including general use medical instruments, basin sets, and procedure trays, with a maximum content weight of 9 lbs. It supports double-wrapping techniques or single-step double-layer wraps from the ONE-STEP portfolio.

Performance and Validation

Validated to maintain sterility for at least 365 days post-sterilization, it features validated dry times for pre-vacuum steam sterilization. The wrap holds FDA 510(k) clearance and meets standards such as AS/NZS 4187, EN ISO 11607, and EN 868-2. It is also CE-marked.

Size and Packaging Options

Available in a variety of sizes, from small squares to large sheets, it is supplied in bulk cartons with quantities tailored to specific needs. This versatility makes it suitable for a wide range of applications in hospitals and pharmaceutical settings.

Handling Instructions

For optimal results, store the wrap in a clean, dust-free environment away from UV light. Conditioning at specific temperatures and humidity levels before use is recommended. Post-sterilization, packages should be allowed to cool before handling, and inspected for any damage or contamination.

Compliance and Guidelines

Adhering to ANSI/AAMI and AORN guidelines, KIMGUARD HH 300 ensures reliable sterility maintenance. As a single-use product, it should not be reused or re-sterilized, aligning with best practices in healthcare settings.

Manufactured in the United States, this mid-strength grade wrap provides dependable performance for maintaining the sterility of essential medical tools and devices.