The Biogel® Super-Sensitive is a sterile, latex surgical glove for extra tactile sensitivity.
Biogel® key features and benefits
• 9/10 surgeons prefer Biogel for fit, feel and comfort1
• Reduced chance of a hole with an industry-leading AQL* result of 0.651
• Every glove (100%) is air inflation tested and visually inspected for quality and safety1
• Improved efficiency as less gloves are wasted
• Non-pyrogenic, potentially reducing the risk of post-operative complications
General information
Contra-indications: This product contains natural rubber latex which may cause allergic reactions including anaphylactic responses.
Allergenicity: Biogel gloves are produced to have low levels of aqueous extractable protein and have been shown to have a low potential for inducing allergic contact dermatitis or ‘Type IV allergy’.
Pyrogenicity: Each batch of Biogel gloves is tested to have a low endotoxin level (< 20 EU/pair).
Product standards: Biogel gloves are tested and manufactured to the following standards:
• Quality/Environmental: ISO 9001, ISO 13485, ISO 14001
• Product: ASTM D3577, EN455-1, EN455-2, EN455-3, EN455-4
• Sterilisation: Gamma irradiation
• Viral Penetration: Bacteriophage test, ASTM F1671
• Allergenicity/Pyrogenicity: ISO 10993 (PART 5 and 10)
Registering authority: In Europe the gloves are CE marked (notified body BSi, number 0086) indicating compliance with Council Directive 93/42/EEC.
In US the gloves are FDA registered. Biogel Surgical gloves are a Class IIa Product.
Storage: Store in a cool, dry place away from sources of heat or direct sunlight.
Packaging: One pair per pack, in a high quality inner wrap, packed into a film pack (constructed of a laminate of polyester and low-density polyethylene). 50 pairs per collation case for sizes 5.5 – 8.5; 40 pairs for size 9.0; 200 pairs per transit case for sizes 5.5 – 8.5; 160 pairs for size 9.0.
Disposal: Gloves & outer wrap dispose of as clinical waste. Paper inner wrap, collation case & transit case can be recycled as paper or disposed
of as clinical waste.
Shelf life: Five (5) years from date of manufacture.
Manufacturer: Made and packed in Malaysia by Mölnlycke Health Care Sdn Bhd.