polychloroprene cleanroom gloves “cytotoxic …€¦ · tm sterile polychloroprene cleanroom...

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TM Sterile Polychloroprene Cleanroom Gloves Length 300mm (12") Polychloroprene ISO Class 4 and EU GMP Grade A Compatible Category 3 EXCELLENT GRIP & CYTOTOXIC PROTECTION BPZS SPECIFICATIONS PRODUCT CERTIFICATIONS Polychloroprene provides excellent chemical protection and tactility MASTER CODE PACKAGING P-Zero www.nitritex.com BioClean is a brand of TM One pair per EasyTear™ pouch 10 pairs per outer bag Free of Amines & Amides Recyclable Components EN 374 LEVEL 2 ? EN 374 LEVEL 2 www.nitritex.com GB10/81851 E R T IF C IC M A E T T I S O Y N S GS S I S O 9 0 0 1 UKAS QUALITY MANAGEMENT 005 E R T IF C IC M A E T T I S O Y N S GS S I S O 3 4 1 UKAS QUALITY MANAGEMENT 005 8 5 GB04/61092 UK e-mail: [email protected] Tel: +44 (0) 1638 663338 Fax: +44 (0) 1638 668890 Nitritex Ltd, CB8 7YY, United Kingdom Latex-free to eliminate Type I latex allergies Textured for improved grip 0120 Excellent anti-static properties Processed to ensure ISO Class 4 & EU GMP Grade A compatibility

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Page 1: Polychloroprene Cleanroom Gloves “CYTOTOXIC …€¦ · TM Sterile Polychloroprene Cleanroom Gloves Length 300mm (12") Polychloroprene ISO Class 4 and EU GMP Grade A Compatible

TM

Sterile

Polychloroprene

Cleanroom Gloves

Length 300mm (12")PolychloropreneISO Class 4 andEU GMP Grade A CompatibleCategory 3

EXCELLENT GRIP &CYTOTOXIC PROTECTION“

BPZS

SPECIFICATIONS PRODUCT CERTIFICATIONS

Polychloroprene providesexcellent chemical

protection and tactility

MASTER CODE PACKAGING

P-Zero

www.nitritex.comBioClean is a brand ofTM

One pair per EasyTear™ pouch10 pairs per outer bagFree of Amines & AmidesRecyclable Components

EN 374

LEVEL 2

?EN 374

LEVEL 2

www.nitritex.comGB10/81851

ERTIF C ICM AE TT IS OY NS

GSS

ISO9001

U K ASQUALITY

MANAGEMENT

005

ERTIF C ICM AE TT IS OY NS

GSS

ISO

3

4

1 U K ASQUALITY

MANAGEMENT

005

85

GB04/61092

UK e-mail: [email protected]

Tel: +44 (0) 1638 663338

Fax: +44 (0) 1638 668890

Nitritex Ltd, CB8 7YY, United Kingdom

Latex-free to eliminateType I latex allergies

Texturedfor improved grip

0120

Excellent anti-staticproperties

Processed to ensureISO Class 4 & EU GMPGrade A compatibility

Page 2: Polychloroprene Cleanroom Gloves “CYTOTOXIC …€¦ · TM Sterile Polychloroprene Cleanroom Gloves Length 300mm (12") Polychloroprene ISO Class 4 and EU GMP Grade A Compatible

MASTER CODE

BPZSRE-ORDER CODE SIZE

BPZS60 6.0

BPZS65 6.5

BPZS70 7.0

BPZS75 7.5

BPZS80 8.0

BPZS85 8.5

BPZS90 9.0

PRODUCT ILLUSTRATION

30

0m

m (

12

")

Natural

BPZS/0813/PDS17

COLOUR: Natural.

LENGTH: 300mm (12").

MATERIAL: Polychloroprene.

SHAPE: Hand specific.

SURFACE: Textured.

OTHER FEATURES: Powder-free, latex-free, beaded cuff.Part of the BioClean-C Chemotherapy range.

PROTEIN LEVEL: Polychloroprene contains no natural latex proteins.

STERILISATION METHOD: Gamma irradiation.

PACKING: Bagged.

AQL: 1.5 freedom from pinholes (1000ml water test).

PARTICULATES: Processed in a cleanroom environment to ensure compatibility withISO Class 4 & EU GMP Grade A operating conditions.

PHYSICAL PROPERTIES: Complies with the requirements of the Glove Standard EN420:2003and the European Medical Gloves Standard (EN455 Parts 1, 2 & 3) & EN374-1, 2 & 3:2003. ASTM 6978-05 tested against cytotoxic drugs.

QUALITY SYSTEMS: Manufactured in a facility holding ISO 9001:2008 and89/686/EEC Article 11b certifications. Processed in an NEBBcertified ISO Class 4 cleanroom environment.

SAMPLING & INSPECTION: In accordance with ISO 2859.

STORAGE INSTRUCTIONS: Store in a dry, cool place (<40°C) away from direct sunlightand fluorescent light.

SHELF LIFE: Five (5) years from date of manufacture.

BAR CODES: Each size carries a unique bar code on the carton (ITF-14) to allow automatic data entry into Stock Control Systems.

LOT NUMBER: This is shown on the sealed pouch and the carton to provideproduct traceability.

PACKAGING: One cuffed pair per plastic wallet;One wallet per EasyTear™ PE pouch;10 pairs per sealed outer PE bag;20 outer bags per carton liner;One carton liner per carton (200 pairs).

COMPATIBILITY: ISO Class 4 & EU GMP Grade A.

CLASSIFICATION: Category 3 - Complex Design Personal Protective Equipment conforming to PPE Directive 89/686/EEC.

TM

Sterile

Polychloroprene

Cleanroom Gloves

P-Zero

EUROPE (Headquarters) [email protected]

MALAYSIA (Manufacturing) [email protected]

AMERICAS [email protected]

SINGAPORE [email protected]

CHINA [email protected]

TM

www.bioclean.com

Contacts: