Description
The BIOGEL PI INDICATOR SYSTEM by Mölnlycke Health Care Sdn Bhd is an advanced surgical glove solution designed to enhance safety and performance in medical environments. This innovative system is crafted from synthetic polyisoprene, offering a latex-free, powder-free option that minimizes the risk of latex sensitivities for healthcare professionals and patients alike.
Puncture Detection
A standout feature of this system is its dual-glove design, comprising a blue indicator underglove and a straw-coloured overglove. This combination provides a unique color contrast that delivers clear and immediate visual indication of glove punctures, proven to detect up to 97% of punctures. Such a feature is crucial in maintaining sterility and protection during surgical procedures.
Comfort and Fit
The gloves are engineered with Biogel hydrogel polymer coating, ensuring easy donning and a comfortable fit. The design includes curved fingers, smooth surfaces, and anti-slip beaded cuffs, allowing the gloves to conform like a second skin. The micro-roughened surface of the underglove enhances tactile sensitivity, reducing hand fatigue and providing a secure grip.
Quality Assurance
Each glove undergoes rigorous quality control, including 100% air-inflation testing for holes and visual inspections. The gloves exhibit low endotoxin levels (<20 EU/pair) and comply with numerous international standards, including ISO 13485 and ASTM D3577. They are CE-marked, UKCA-marked, and FDA-cleared, ensuring adherence to high medical device standards.
Sterilization and Shelf Life
The gloves are sterilized using gamma irradiation, achieving a sterility assurance level of 10^-6. They offer a shelf life of three years from the date of manufacture, provided they are stored in a dry environment at temperatures between 5–25°C, away from heat and sunlight.
Packaging and Environmental Considerations
Packaging is designed for clinical use, with each pair individually packed. Standard packaging includes 2 x 25 pairs per box, with 4 boxes per case. The packaging materials are recyclable where possible and use FSC certified paper, aligning with environmental sustainability goals.
Intended Use
The BIOGEL PI INDICATOR SYSTEM is ideal for a wide range of surgical specialties, including cardiovascular, orthopedic, and neurosurgery, among others. It is suitable for use in aseptic environments and has been tested for compatibility with chemotherapy agents, making it a versatile choice for various medical applications.
This comprehensive glove system represents a commitment to quality, safety, and environmental responsibility, providing healthcare professionals with the reliable protection they need in demanding surgical settings.
