Medical & Lab
Nitritex offer a wide range of medical products that meet EN 455 standards. Our Omega. and Profile. range includes gloves and facemasks in both sterile and non-sterile versions, with a variety of materials including latex, nitrile, polychloroprene and vinyl.
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Style/Type
Headloop
(2)
Earloops
(2)
Tie-On
(2)
Colour
White
(6)
BioClean™ DB
BDBS
BREATHABILITY & COMFORT
- Brand:
- BioClean™
- Colour:
- White
- Style/Type:
- Headloop
- Sterile:
- Sterile
- Construction:
- Seams: Ultrasonically bonded.
Outer facing: Spunbond polyester (non-woven).
Filter layer: Meltblown polyester.
Inner facing: Spunbond polyester (non-woven).
Headloops: Tubular knitted polyurethane Spandex yarn.
Spacer: Non-latex band.
Nose bridge: Fully enclosed coated malleable aluminium.
- Sterilisation Method:
- Gamma irradiation.
- Physical Properties:
- Particle filtration efficiency (PFE): 98.2%
Bacteria filtration efficiency (BFE): 97.9%
Differential pressure drop in mm H2O/cm2 3.57
- Packing:
- Bagged
- Particulates:
- Processed in a cleanroom environment to ensure compatibility with ISO Class 4 operating conditions.
- Quality Systems:
- Manufactured in a facility holding the following registrations: ISO 9001:2008 and ISO 13485:2003.
- Sampling & Inspection:
- In accordance with ISO 2859 standard procedures.
- Storage Instructions:
- Store in a dry, cool place (<40°C) away from direct sunlight and fluorescent light.
- Shelf Life:
- Five (5) years from date of manufacture.
- Bar Codes:
- This is shown on the carton to allow automatic data entry into Stock Control Systems.
- Lot Number:
- This is shown on the sealed outer bag and the carton to provide product traceability.
- Packaging:
- 1 mask per inner bag;
20 inner bags per outer bag;
10 outer bags per carton (200 pieces).
- Compatibility:
- ISO Class 4 & EU GMP Grade A.
- Product Codes
and Sizes: -
BDBS: Universal
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BioClean™ DB
BDBS-G
BREATHABILITY & COMFORT
- Brand:
- BioClean™
- Colour:
- White
- Style/Type:
- Headloop
- Sterile:
- Sterile
- Construction:
- Seams: Ultrasonically bonded.
Outer facing: Spunbond polyester (non-woven).
Filter layer: Meltblown polyester.
Inner facing: Spunbond polyester (non-woven).
Headloops: Tubular knitted polyurethane Spandex yarn.
Neck guard: Spunbond non-woven polyester.
Spacer: Non-latex band.
Nose bridge: Fully enclosed coated malleable aluminium.
- Sterilisation Method:
- Gamma irradiation.
- Physical Properties:
- Particle filtration efficiency (PFE): 98.2%
Bacterial filtration efficiency (BFE): 97.9%
Differential pressure drop in mm H<sub>2</sub>O/cm<sup>2</sup> 3.57
- Packing:
- Bagged
- Quality Systems:
- Produced in a facility registered to ISO 9001:2008 and ISO 13485:2003.
- Sampling & Inspection:
- In accordance with ISO 2859 standard procedures.
- Storage Instructions:
- Store in dry, cool place (<40°C) away from direct sunlight and fluorescent light.
- Shelf Life:
- Five (5) years from date of manufacture.
- Bar Codes:
- This is shown on the carton to allow automatic data entry into Stock Control Systems.
- Lot Number:
- This is shown on the sealed outer bag and the carton to provide product traceability.
- Packaging:
- 1 mask per inner bag;
20 inner bags per outer bag;
10 outer bags per carton (200 pieces).
- Compatibility:
- ISO Class 4 & EU GMP Grade A.
- Product Codes
and Sizes: -
BDBS-G: Universal
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BioClean™ MEA
MEA
ULTRA-LOW PARTICULATION
- Brand:
- BioClean™
- Colour:
- White
- Style/Type:
- Earloops
- Size:
- 210mm.
- Sterile:
- Non-Sterile
- Construction:
- 3 ply - Ultrasonic sealing.
Outer facing: Hydrophobic Polypropylene/PE (non-woven).
Filter layer: Meltblown Polypropylene.
Inner facing: Hydrophilic Polypropylene/PE (non-woven).
Earloops: Polyurethane.
Nose-band: Fully enclosed coated malleable aluminium.
- Physical Properties:
- Particle filtration efficiency (PFE): >98%
Bacterial filtration efficiency (BFE): >97%
Pressure drop (Delta P): 2.7
- Packing:
- Bagged
- Particle Shedding Analysis:
- Average Particle Count = 19/minute (Particle size: 0.2 - 5.0 microns). Test method: ASTM F51-68 (1989).
- Quality Systems:
- Produced in a facility registered to ISO 9001:2008 and ISO 13485:2003.
- Sampling & Inspection:
- In accordance with ISO 2859 standard procedures.
- Storage Instructions:
- Store in dry, cool place (<40°C) away from direct sunlight and fluorescent light.
- Shelf Life:
- Five (5) years from date of manufacture.
- Lot Number:
- This appears on all the bags and the carton to provide product traceability.
- Packaging:
- MEA 210-0 - (Bulk)
100 pieces per sealed inner bag;
One inner bag per sealed outer bag;
20 outer bags per carton (2000 pieces).
MEA 210-2 (Single) with clips.
1 piece per sealed pouch;
50 pouches per sealed outer bag;
12 outer bags per carton (600 pieces).
Non-stock item. Minimum order quantity 50 cartons.
- Product Codes
and Sizes: -
MEA 210-0: bulk
MEA 210-2: single with clips
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BioClean™ MEA (Sterile)
MEA210-1
ULTRA-LOW PARTICULATION
- Brand:
- BioClean™
- Colour:
- White
- Style/Type:
- Earloops
- Size:
- 210mm.
- Sterile:
- Sterile
- Construction:
- 3 ply - Ultrasonic sealing.
Outer facing: Hydrophobic Polyester (non-woven).
Filter layer: Meltblown Polyester.
Inner facing: Hydrophilic Polypropylene (non-woven).
Earloops: Polyurethane.
Nose-band: Fully enclosed coated malleable aluminium.
- Sterilisation Method:
- Gamma irradiation.
- Physical Properties:
- Particle filtration efficiency (PFE): >96%
Bacterial filtration efficiency (BFE): >94%
Pressure drop (Delta P): 3.2
- Packing:
- Bagged
- Particle Shedding Analysis:
- Average Particle Count = 19/minute (Particle size: 0.2 - 5.0 microns). Test method: ASTM F51-68 (1989).
- Quality Systems:
- Produced in a facility registered to ISO 9001:2008 and ISO 13485:2003.
- Sampling & Inspection:
- In accordance with ISO 2859 standard procedures.
- Storage Instructions:
- Store in dry, cool place (<40°C) away from direct sunlight and fluorescent light.
- Shelf Life:
- Five (5) years from date of manufacture.
- Lot Number:
- This is shown on the bags and the carton to provide product traceability.
- Packaging:
- MEA 210-1 (Single) with clips
1 piece per sealed pouch;
50 pouches per sealed outer bag;
12 outer bags per carton (600 pieces)
- Product Codes
and Sizes: -
MEA 210-1: single with clips
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BioClean™ MTA
MTA
ULTRA-LOW PARTICULATION
- Brand:
- BioClean™
- Colour:
- White
- Style/Type:
- Tie-on
- Size:
- 210mm.
- Sterile:
- Non-Sterile
- Construction:
- 3 ply - Ultrasonic sealing.
Outer facing: Hydrophobic Polypropylene/PE (non-woven).
Filter layer: Meltblown Polypropylene.
Inner facing: Hydrophilic Polypropylene/PE (non-woven).
Ties: Polypropylene.
Nose-band: Fully enclosed coated malleable aluminium.
- Physical Properties:
- Particle filtration efficiency (PFE): >98%
Bacterial filtration efficiency (BFE): >97%
Pressure drop (Delta P): 2.7
- Packing:
- Bagged
- Particle Shedding Analysis:
- Average Particle Count - 19/minute (Particle size: 0.2 - 5.0 microns). Test method: ASTM F51-68 (1989).
- Quality Systems:
- Produced in a facility registered to ISO 9001:2008 and ISO 13485:2003.
- Sampling & Inspection:
- In accordance with ISO 2859 standard procedures.
- Storage Instructions:
- Store in dry, cool place (<40°C) away from direct sunlight and fluorescent light.
- Shelf Life:
- Five (5) years from date of manufacture.
- Lot Number:
- This is shown on all the bags and the carton to provide product traceability.
- Packaging:
- MTA 210-0 Bulk packed
50 pieces per sealed inner bag;
One inner bag per sealed outer bag;
16 outer bags per carton (800 pieces).
MTA 210-2 Single packed
One piece per sealed pouch;
50 pouches per sealed outer bag;
10 outer bags per carton (500 pieces)
- Product Codes
and Sizes: -
MTA 210-0: bulk
MTA 210-2: single
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BioClean™ MTA (Sterile)
MTA210-1
ULTRA-LOW PARTICULATION
- Brand:
- BioClean™
- Colour:
- White
- Style/Type:
- Tie-on
- Size:
- 210mm.
- Sterile:
- Sterile
- Construction:
- 3 ply - Ultrasonic sealing.
Outer facing: Hydrophobic Polyester (non-woven).
Filter layer: Meltblown Polyester.
Inner facing: Hydrophilic Polypropylene/PE (non-woven).
Ties: Polyester.
Nose-band: Fully enclosed coated malleable aluminium.
- Sterilisation Method:
- Gamma irradiation.
- Physical Properties:
- Particle filtration efficiency (PFE): >96%
Bacterial filtration efficiency (BFE): >94%
Pressure drop (Delta P): 3.2
- Packing:
- Bagged
- Particle Shedding Analysis:
- Average Particle Count - 19/minute (Particle size: 0.2 - 5.0 microns). Test method: ASTM F51-68 (1989).
- Quality Systems:
- Produced in a facility registered to ISO 9001:2008 and ISO 13485:2003.
- Sampling & Inspection:
- In accordance with ISO 2859 standard procedures.
- Storage Instructions:
- Store in dry, cool place (<40°C) away from direct sunlight and fluorescent light.
- Shelf Life:
- Five (5) years from date of manufacture.
- Lot Number:
- This is shown on the bags and the carton to provide product traceability.
- Packaging:
- MTA 210-1 single packed
One piece per sealed pouch;
50 pouches per sealed outer bag;
10 outer bags per carton (500 pieces).
- Product Codes
and Sizes: -
MTA 210-1: single pack
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© 2008 Nitritex Ltd, Minton Enterprise Park, Oaks Drive, Newmarket, Suffolk, CB8 7YY
Company Reg No 3231971 (England & Wales) - VAT Number GB 676 8083 88