Description

The BIOGEL PI MICRO INDICATOR SYSTEM, crafted 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 features a synthetic, non-latex, sterile, and powder-free double-glove configuration, making it suitable for a wide range of surgical procedures, particularly for those with latex sensitivities.

Key Features

• Enhanced Safety: The system includes a blue polyisoprene underglove and a straw-colored overglove. This combination provides a clear and immediate visual indication of glove perforation, detecting up to 97% of punctures when double-gloving.

• Superior Sensitivity: Each glove is extra-thin, 20–25% thinner than standard synthetic gloves, offering exceptional tactile sensitivity and dexterity without compromising protection.

• Comfort and Fit: Designed to conform to the hand like a second skin, these gloves reduce hand fatigue. Features such as curved fingers, a smooth surface, and an anti-slip beaded cuff ensure a secure and comfortable fit.

Quality and Reliability

• Rigorous Testing: Each glove undergoes 100% air-inflation testing and visual inspection to ensure freedom from holes, boasting an industry-leading AQL of 0.65.

• Low Endotoxin Levels: With low endotoxin levels, these gloves are suitable for sensitive surgical environments.

• Durability: The gloves maintain high tensile strength and elongation, with specific force at break measurements ensuring reliability both initially and after aging.

Certifications and Standards

The BIOGEL PI MICRO INDICATOR SYSTEM meets or exceeds numerous international standards, including ISO 9001, ISO 13485, and ASTM D3577. It is certified as both a Medical Device and PPE, with CE marking in Europe and 510(k) clearance in the USA.

Sterilization and Shelf Life

• Sterilization Method: The gloves are sterilized using gamma irradiation.
• Shelf Life: They offer a shelf life of 3 years from the date of manufacture.

Packaging and Sizes

• Sizes Available: Overglove sizes range from 5.5 to 8.5, while underglove sizes range from 5.5 to 9.0.
• Packaging Configuration: Standard packaging includes 25 pairs per box, with double-packing for sterility. Size 9.0 is packaged with 40 pairs per box.

Intended Use

These gloves are recommended for a variety of surgical disciplines, including cardiovascular, neurosurgery, and orthopedic procedures. They are also tested for use with chemotherapy agents, broadening their applicability in specialized medical settings.

Storage and Disposal

• Storage Conditions: Store at temperatures between 5–25°C, away from heat and sunlight.
• Disposal: Dispose of as clinical waste or recycle appropriately, aligning with environmental considerations.

The BIOGEL PI MICRO INDICATOR SYSTEM represents a commitment to surgical excellence, providing healthcare professionals with the confidence and comfort needed to perform at their best.