Description

The Biogel PI Micro Indicator System by Mölnlycke Health Care is an advanced surgical glove solution designed to enhance safety and performance in medical environments. This innovative system features a unique double-gloving design, comprising a blue polyisoprene underglove and a straw-colored overglove. The primary advantage of this system is its puncture indication capability, providing a clear, fast, and large visual alert in the event of glove perforation, with detection rates of up to 97%.

Key Features

• Material Composition: Crafted from synthetic polyisoprene, these gloves are non-latex, significantly reducing the risk of latex-related allergies. They are also powder-free, minimizing complications associated with glove powder.

• Enhanced Tactile Sensitivity: The gloves are 20–25% thinner than standard Biogel PI gloves, offering superior tactile sensitivity without compromising on protection.

• Surface and Fit: Designed with a smooth, micro-roughened surface, curved fingers, and a beaded anti-slip cuff, these gloves ensure a secure fit and ease of donning. The ergonomic design conforms to the hand, enhancing comfort and reducing fatigue during prolonged use.

Performance and Safety

• Low Endotoxin Levels: The gloves exhibit low endotoxin levels (<20 EU/pair), are non-pyrogenic, and have low accelerator content, which helps in minimizing allergic reactions and fever responses.

• Rigorous Testing: Each glove undergoes 100% air-inflation testing for holes and is visually inspected to ensure quality. They are also tested and cleared for use with chemotherapy agents, adhering to ASTM D6978 standards.

Certifications and Compliance

• Certifications: The Biogel PI Micro Indicator System is CE-marked, UKCA-marked, and FDA-cleared. It meets various international standards, including ISO 9001, ISO 13485, and ISO 14001, among others.

• Sterilization and Shelf Life: The gloves are sterilized through gamma irradiation and have a shelf life of three years from the date of manufacture.

Environmental Considerations

• Packaging: The gloves are packaged using FSC-certified paper, with options for clinical waste disposal and recycling, aligning with environmental sustainability goals.

Physical Properties

• Thickness:
• Cuff: 0.16 mm
• Palm: 0.19 mm

• Finger: 0.21 mm

• Force at Break:

• Overglove: 15 N (initial), 12 N (aged)

• Underglove: 12 N (initial), 10 N (aged)

• AQL (Freedom from Holes): 0.65

Sizing and Packaging

Available in sizes ranging from 5.5 to 9, the gloves are packaged in boxes of 50 pairs, with size 9 available in boxes of 40 pairs. Various packaging configurations are offered to meet different logistical needs.

Recommended Use

Ideal for a wide range of surgical procedures, particularly where tactile sensitivity and latex allergy prevention are crucial. Suitable for specialties such as cardiovascular, endovascular, ENT, general abdominal, and more.

Storage Instructions

Store the gloves in a dry place at temperatures between 5–25°C, away from direct heat and sunlight, to maintain their integrity and performance.