Description

The Biogel PI Indicator System is an advanced surgical glove solution designed to enhance safety and performance in the operating room. This innovative system features a double-gloving technique with a blue underglove and a straw-coloured overglove, both crafted from synthetic polyisoprene. This material choice ensures that the gloves are latex-free, making them ideal for individuals with latex allergies.

Key Features

• Puncture Detection: The system provides a clear visual indication of glove perforation, detecting up to 97% of punctures when double-gloving. This feature significantly enhances surgical safety by reducing the risk of contamination.

• Ergonomic Design: The gloves are designed with a curved finger shape for a comfortable fit, reducing hand fatigue. The smooth surface and micro-roughened, anti-slip beaded cuff facilitate easy donning and secure handling of instruments.

• Tactile Sensitivity: Available in extra-thin options, the gloves offer enhanced tactile sensitivity, being 20–25% thinner than standard Biogel PI gloves, allowing for precise movements during delicate procedures.

• Powder-Free and Non-Pyrogenic: These attributes contribute to a cleaner surgical environment and reduce the risk of adverse reactions.

Quality and Performance

• Rigorous Testing: Each glove is 100% air-inflation tested for holes and visually inspected to ensure quality. The gloves boast an industry-leading Acceptable Quality Level (AQL) of 0.65 for freedom from holes.

• Low Endotoxin Levels: With low endotoxin levels, the gloves are suitable for sensitive medical applications.

• Physical Durability: The gloves exhibit high tensile strength and elongation at break, with specific thickness measurements for different glove areas to ensure durability and flexibility.

Sterilization and Certification

• Gamma Sterilized: Ensures a high level of sterility (SAL 10^-6), making the gloves suitable for a wide range of surgical procedures.

• Comprehensive Certification: The gloves are certified as Medical Devices and Personal Protective Equipment, meeting numerous international standards for quality, environmental management, and safety.

• Regulatory Approvals: CE-marked, UKCA-marked, and FDA-cleared, providing assurance of compliance with global medical device regulations.

Packaging and Environmental Considerations

• Size Range: Available in a variety of sizes, with packaging that includes double-packing for sterility. Each box contains 25 pairs, with variations depending on glove size.

• Recyclable Materials: Packaging uses ISCC and FSC certified paper, promoting environmental responsibility.

Manufacturer Information

Produced by Mölnlycke Health Care Sdn Bhd in Malaysia, the Biogel PI Indicator System is a trusted choice for healthcare professionals across various surgical disciplines, including cardiovascular, orthopedic, and neurosurgery. Suitable for use in aseptic and cleanroom environments, this glove system supports optimal surgical outcomes through superior protection and performance.