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BDBS-G

Product catalog summary

Product Overview: The BioClean DB Sterile Pouch-style Facemask with Neck Guard is designed for enhanced comfort and protection. It features a large breathing chamber and an integrated neck guard to minimize cross-contamination risks. The facemask is made from cleanroom-compatible materials.

Materials: The facemask consists of a non-woven spunbonded polyester inner and outer layer, a meltblown polyester filter layer, polyurethane Spandex yarn headloops, a non-woven spunbonded polyester neck guard, and a plastic-coated steel nose-band.

Key Features: The facemask offers high bacterial and particle filtration efficiency, an extra-long neck guard, a large breathing chamber, ultrasonically sealed edges, and a fully enclosed malleable nose-band. It is compatible with ISO Class 4 environments.

Quality Standards: Manufactured in an ISO 9001:2015 certified facility and processed in an NEBB certified ISO Class 4 cleanroom. Sampling and inspection follow ISO 2859-3:1992 standards.

Sterilization: The facemask is sterilized using gamma irradiation with a minimum dose of 25kGy, ensuring a sterility assurance level of 10^-6.

Shelf Life & Storage: The product has a shelf life of five years from the date of manufacture. It should be stored in a dry, cool place below 40°C, away from direct sunlight and fluorescent light.

Contact Information: The document provides contact details for Nitritex Ltd in the UK, Ansell US in the USA, and Nitritex (M) Sdn.Bhd in Malaysia.

Ordering Information: The facemask is available under the re-order code BDBS-G. It is packed with one piece per sealed inner PE bag, 20 inner bags per sealed outer PE bag, and 10 outer bags per lined carton, totaling 200 pieces.

Physical Properties: The facemask is white, with headloops, and measures 301mm in length and 100mm in width. The neck guard measures 245mm in length and 210mm in width.

Performance Information: The facemask is compatible with ISO Class 4 and EU GMP Grade A environments. It has a particle filtration efficiency of 98.2% at 0.3 microns, a bacterial filtration efficiency of 97.9% at 3.0 microns, and a viral filtration efficiency of 98.5%. The differential pressure is 3.57 mm H₂O/cm².

Disclaimer: The document includes a disclaimer stating that it should not be construed as a warranty of merchantability or fitness for a particular purpose. Ansell assumes no responsibility for the suitability of the facemask for specific applications.

Catalog excerpts

About The BioClean DB Pouch-style Sterile Facemask features a large breathing chamber for increased wearer comfort. Made from cleanroom compatible materials the BioClean DB facemask features an integrated neck guard to provide additional coverage reducing the risk of cross-contamination. BIOCLEAN DB Sterile Pouch-style Facemask with Neck Guard BDBS-G INNER FACING LAYER: Non-woven spunbonded polyester (hygroscopic) FILTER LAYER: Meltblown polyester OUTER FACING LAYER: Non-woven spunbonded polyester (hydrophobic) FASTENINGS: Tubular knitted polyurethane Spandex yarn headloops NECK GUARD: Non-woven spunbonded polyester NOSE-BAND: Plastic coated steel Features • High bacterial & particle filtration efficiency • Extra long neck guard • Large breathing chamber • Ultrasonically sealed edges • Fully enclosed malleable nose-band

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Quality Standards • Manufactured in a facility holding ISO 9001:2015 • Processed in an NEBB certified ISO Class 4 cleanroom environment • Sampling and inspection in accordance with ISO 2859-3:1992 Method: Gamma irradiation Minimum Dose: 25kGy Sterility Assurance Level: 10-6 Shelf Life & Storage Five (5) years from date of manufacture. Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light. Physical Properties Re-order code BDBS-G Packing One piece per sealed inner PE bag; 20 inner bags per sealed outer PE bag; 10 outer bags per lined carton (200 pieces) For additional...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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