Description

The Biogel PI Indicator Underglove is an essential component for surgical environments where safety and sensitivity to latex are paramount. Crafted from synthetic polyisoprene, this sterile, powder-free glove is designed to be worn beneath Biogel surgical gloves, forming part of the innovative Biogel Puncture Indication System.

Key Benefits

• Puncture Indication: The underglove's blue color provides clear and immediate puncture indication, enhancing safety by detecting up to 97% of glove breaches when double-gloving.
• Latex-Free: Offers the fit, feel, and comfort akin to natural rubber latex without the associated sensitization risks, making it ideal for those with latex allergies.

Design Features

• Comfort and Fit: Features such as curved fingers and a smooth outer surface ensure easy donning and a comfortable fit.
• Beaded Cuff: Each glove is hand-specific with a beaded cuff to prevent roll-down, maintaining sterility and ease of use.

Quality Assurance

• Sterility and Testing: Each glove is sterilized by gamma irradiation, achieving a Sterility Assurance Level of 10^-6. Rigorous quality checks include 100% air inflation testing and visual inspections to ensure exceptional barrier protection.
• AQL Rating: With an Acceptable Quality Level of 0.65, the glove promises minimal defects post-packaging.

Biocompatibility

• Low Endotoxin Levels: Endotoxin levels are kept below 20 EU per pair, and the glove is non-pyrogenic with low dermatitis potential.
• Compliance: Meets international standards such as ISO 10993, ensuring it is not an irritant or sensitizer.

Certifications

This glove is a certified Medical Device and PPE Category III, with CE marking in Europe, UKCA marking in the UK, and 510(k) clearance in the USA. It complies with standards like ASTM D3577 and EN455, underscoring its reliability and performance.

Physical Properties

• Dimensions: Available in sizes 5.5 to 9, with lengths ranging from 285 to 301 mm.
• Thickness: The glove's thickness is strategically varied across the cuff, palm, and fingers to balance protection and tactile sensitivity.
• Durability: Exhibits high tensile strength and elongation at break, maintaining performance even after aging.

Intended Use

Ideal for a wide range of surgical procedures, including cardiovascular, gynecological, orthopedic, and general surgeries. It is particularly beneficial in settings where latex allergies are a concern.

Storage and Packaging

• Shelf Life: Three years, with storage recommended in a dry place at temperatures between 5–25°C.
• Packaging: Each box contains 50 pairs (sizes 5.5–8.5) or 40 pairs (size 9), with appropriate disposal methods advised for clinical settings.

Manufactured in Malaysia, the Biogel PI Indicator Underglove is a trusted choice for healthcare professionals seeking superior protection and performance in surgical settings.