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Bioclean Barrier Plus Gauntlet

Bioclean Barrier Plus Gauntlet

Bioclean Barrier Plus Gauntlet

Product catalog summary
Product Overview: BioClean BarrierPlus™ Gauntlets are sterile gloves made from accelerator-free nitrile, designed for use in product contact areas. They offer excellent electrostatic discharge (ESD) properties and are validated for sterility with a Sterility Assurance Level (SAL) of 10⁻⁶. Available in lengths up to 840mm (33 inches) and port sizes ranging from 150mm to 300mm (6 to 12 inches).
Specifications:
  • Compatibility: ISO Class 4 & EU GMP Grade A
  • Material: Nitrile, free from natural latex proteins
  • Surface: Smooth
  • Shape: Five-fingered gauntlet, size 9.0
  • Color: White
  • Sterilization: Gamma irradiation
Features:
  • Tested against ASTM D6978-05 for handling chemotherapy drugs
  • 100% air leak tested
  • Ultra-clean surface for product protection
  • Designed to minimize hand fatigue
  • Suitable for autoclaving and can be sanitized by VHP or IPA
Quality Standards: Manufactured in an ISO 9001:2008 certified facility, conforming to PPE Directive 89/686/EEC, and processed in an NEBB certified ISO Class 4 environment. Complies with EN420:2003, EN374-1, 2 & 3:2003, and EN455-2:2009 standards.
Sterilization: Method: Gamma irradiation with a minimum dose of 25kGy, ensuring a Sterility Assurance Level of 10⁻⁶.
Shelf Life: Three years from the date of manufacture.
Physical Properties:
  • Freedom From Holes: 0.65 AQL
  • Minimum Length: 840mm (33 inches)
  • Single Wall Thickness: Cuff: 0.3mm, Palm: 0.5mm, Finger Tip: 0.6mm
  • Force At Break: ≥6 N
Protection Against Mechanical Risks:
  • Abrasion Resistance: Level 3
  • Tear Resistance: Level 0
  • Blade Cut Resistance: Level 1
  • Puncture Resistance: Level 1
Ordering Information: Available in sizes for port dimensions 6-7.5 inches, 8-9.5 inches, and 10-12 inches. Packed in multiple layers of sealed polyethylene bags for protection.
Contact Information: For orders and inquiries, contact Nitritex Ltd. in Europe or regional offices in Asia and the Americas.
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Catalog excerpts

Bioclean Barrier Plus Gauntlet-1

Sterile Gauntlet About BioClean BarrierPlus™ Gauntlets are manufactured from accelerator-free nitrile with incredibly low levels of particles and excellent ESD properties. Designed for use in product contact areas, BarrierPlus gauntlets are fully validated for sterility with an SAL (Sterility Assurance Level) of 10-6 and are available in lengths of up to 840mm (33”) and three port sizes from 150mm to 300mm (6.0” to 12”). S-BBNG 100% INSPECTED AND AIR LEAK TESTED SUITABLE FOR AUTOCLAVING CAN BE SANITIZED BY VHP OR IPA Specifications COMPATIBILITY: ISO Class 4 & EU GMP Grade A LENGTH: 840mm (33") MATERIAL: Nitrile PROTEIN LEVEL: Nitrile contains no natural latex proteins SURFACE: Smooth SHAPE: Five fingered gauntlet, size 9.0 COLOUR: White STERILIZATION: Gamma irradiation Features Tested against ASTM D6978-05 for handling chemo drugs 100% air leak tested Ultra-clean surface ensures product protection Specially designed to minimize hand fatigue Suitable for port sizes 150mm - 300mm (6" to 12") Ms.G.Love™ represents BioClean's range of cleanro

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Bioclean Barrier Plus Gauntlet-2

Quality Standards Manufactured in a facility holding ISO 9001: 2008 and 89/686/EEC Article 11b certifications Conforms to Category 3 - Complex Design Personal Protective Equipment PPE Directive 89/686/EEC Processed in an NEBB certified ISO Class 4 environment Complies with the requirements of Glove Standard EN420:2003 and EN374-1, 2 & 3:2003 Physical properties comply with European Medical Glove Standard EN455-2:2009 Tested against permeation standard ASTM D6978-05 for cytotoxic drugs Sterilized in accordance with ISO 11137-1:2006 Method: Gamma irradiation Minimum Dose: 25kGy Sterility Assurance...

 Open the catalog to page 2
Bioclean Barrier Plus Gauntlet-3

Re-order code One piece per sealed inner PE bag; one inner bag per sealed second inner PE bag; one second inner bag per sealed outer PE bag; 20 outer bags per lined inner white Correx polyethylene box; two inner Correx polyethylene boxes per outer white Correx polyethylene box (40 pieces) Beyond Critical Supplies Europe (Headquarters) Minton Enterprise Park, Oaks Drive, Newmarket, Suffolk, United Kingdom Other Regions Asia: ma la vsia (Sbioclean.com BioClean™ is a brand of Nitritex Ltd. For more information, please visitwww.bioclean.com

 Open the catalog to page 3

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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.