Description

The SURGICAL GOWN PRIMARY PLUS is a high-quality, single-use gown designed to meet the demanding needs of operating room environments. Manufactured by Xuchang Zhengde Envirostarn Medical Products Co. Ltd. and distributed by Mölnlycke Health Care, this gown provides essential protection for both medical staff and patients against the transfer of microorganisms, body fluids, and particles.

Key Features

• Performance Versions: Available in both Standard and High Performance versions, aligning with AAMI Levels 2 and 3, and EN 13795 standards. This ensures a suitable barrier for various surgical procedures.
• Material Composition: Made from SMS nonwoven polypropylene with a weight of 35g/m², complemented by breathable laminated fabric reinforcements in critical zones. This design enhances comfort while maintaining fluid repellency.
• Design and Fit: The T-cut design, ergonomic sleeves, and shoulder pleats offer an enhanced fit and ease of movement, making it ideal for low-fluid procedures.
• Closure System: Equipped with a nylon hook-and-loop fastener for secure fitting.
• Additional Accessories: Includes two cellulose hand towels per gown.

Safety and Compliance

• Sterilization: Ethylene oxide sterilization ensures the gown's sterility, with non-sterile options also available.
• Hypoallergenic: Free from latex, phthalates, and animal or biological products, reducing the risk of allergic reactions.
• Sustainability: Features ISCC certified materials and FSC certified paper packaging, contributing to environmental sustainability.

Size and Packaging

• Size Range: Available in sizes from L to XXL-XXL, with lengths ranging from 119 cm to 157 cm and widths from 150 cm to 184 cm.
• Packaging Options: Offered in various packaging configurations, including individual dispenser boxes and three-layer packaging, with pack quantities ranging from 14 to 20 pieces per box.

Regulatory Standards

• Medical Device Classification: Classified as a Class IIs medical device under EU Directive 93/42/EEC.
• Compliance: Meets flammability and biocompatibility standards, with high resistance to microbial and liquid penetration, ensuring robust barrier protection.
• Durability: Demonstrates strong bursting and tensile strength, along with wet traction resistance, enhancing its reliability during use.

Additional Benefits

• Shelf Life: Offers a shelf life of 5 years when stored under normal conditions in intact packaging.
• Traceability: Includes traceability labeling for effective inventory management.
• Documentation: Comprehensive documentation such as user manuals and technical data sheets is available upon request.
• Integration: Can be included in Mölnlycke Procedure Packs, enhancing efficiency in surgical settings.

The SURGICAL GOWN PRIMARY PLUS stands out as a reliable and versatile option for healthcare professionals, ensuring safety, comfort, and compliance with essential medical standards.