Description

The BIOGEL PI MICRO INDICATOR SYSTEM by Mölnlycke Health Care Sdn Bhd is an advanced surgical glove solution designed to enhance safety and performance in the operating room. This innovative system is crafted from synthetic polyisoprene, making it latex-free and suitable for individuals with latex allergies. Each glove is sterile and powder-free, reducing the risk of powder-related complications and ensuring a clean surgical environment.

Key Features

• Double-Gloving System: The system includes a blue underglove and a straw-colored overglove, providing a clear and immediate visual indication of punctures. This feature significantly enhances perforation detection, with proven efficacy in identifying up to 97% of glove punctures.

• Enhanced Tactile Sensitivity: The gloves are 20–25% thinner than standard Biogel PI gloves, offering superior tactile sensitivity without compromising protection. This makes them ideal for procedures where precision and touch are critical.

• Comfort and Fit: Designed to mimic the fit and feel of natural rubber latex, these gloves conform to the hand, reducing fatigue. The beaded cuff and curved finger design ensure a secure fit and ease of use.

Performance and Safety

The BIOGEL PI MICRO INDICATOR SYSTEM boasts a low endotoxin level (<20 EU/pair) and an AQL of 0.65, indicating exceptional quality in freedom from holes. Each glove undergoes rigorous testing, including 100% air-inflation and visual inspections, to ensure reliability.

• Physical Properties:
• Force at Break: Overglove: 15N; Underglove: 12N (initial), 10N (aged)
• Tensile Strength and Elongation: High, maintaining integrity both initially and after aging
• Typical Single Wall Thickness:
  • Cuff: 0.16 mm
  • Palm: 0.19–0.20 mm
  • Finger: 0.21 mm

Applications

These gloves are recommended for a wide range of surgical procedures, including cardiovascular, endovascular, ENT, general abdominal, gynecological, laparoscopic, neurosurgery, and more. Their design is particularly beneficial in settings where glove puncture is likely or where enhanced tactile sensitivity is required.

Certifications and Compliance

The system is certified as both a Medical Device (MD) and Personal Protective Equipment (PPE), with CE and UKCA markings and FDA 510(k) clearance. It complies with relevant standards such as EN 455, ASTM D3577, and ISO certifications, ensuring adherence to high-quality and environmental management standards.

Packaging and Environmental Considerations

Available in various sizes, the gloves are packaged with two pairs per pack, and the packaging components are recyclable. Proper disposal as clinical waste is recommended to minimize environmental impact.

Shelf Life and Storage

With a shelf life of three years, the gloves should be stored in a dry place at temperatures between 5–25°C to maintain their quality and performance over time. This comprehensive system offers healthcare professionals a reliable and sensitive tool for safer surgical outcomes.