• Longer chemical breakthrough time1

• Reduced chance of a hole with an industry-leading AQL* result of 0.652

• Every glove (100%) is air inflation tested and visually inspected for quality and safety

• Non-pyrogenic, potentially reducing the risk of post-operative complications

Recommended for surgeries where a longer chemical breakthrough time is desired or where latex allergies are a concern for the patients or clinicians. Double gloving with the Biogel® Skinsense® Indicator® Underglove is recommended. For surgical procedures involving bone cement please see reverse for breakthrough times.

Biogel has an industry leading freedom from holes AQL* of 0.65. The industry standard requirement for AQL* is 1.5. The lower the number, the fewer the holes and the higher the quality of glove. Biogel is proven to have the lowest glove failure rate among major competitors. Non-Biogel gloves are at least 3.5 times as likely to fail than Biogel gloves.

•Synthetic polychloroprene

•Biogel hydrogel polymer coating

•Micro-roughened surface

•Beaded cuff

•Powder-free

•Non-pyrogenic

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, EN388,EN420, EN374, EN 374-2, EN374-3

• 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: Three (3) years from date of manufacture.

Manufacturer: Made and packed in Malaysia by Mölnlycke Health Care Sdn Bhd.