Nitrile

  • Cleanroom Gloves holding medication on a decorative background
    Cleanroom gloves with a decorative backgroundCleanroom gloves in a box with a decorative background

    Isofield NS300

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • Non-sterile nitrile Cleanroom gloves
    • 300mm (12”) length
    • Ambidextrous
    • White colour
    • Textured fingers
    • Beaded cuff
    • Low endotoxin levels

    • ISO Class 4 cleanroom
    • ISO Class 5 cleanroom
    • Class 10 cleanroom
    • Class 100 cleanroom

    Manufactured in a facility operating under ISO 9001 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom Physical properties comply with European medical glove standard EN455-2:2015

    20130

    Small 20130S
    Medium  20130M
    Large  20130L
    XLarge  20130XL
    XXLarge  20130XXL

    • Shelf Life
    • Three (3) years from date of manufacture
    • Storage
    • Store in a dry, cool place (<40°C) away from direct sunlight
    • Do not expose open cartons to prolonged direct fluorescent light

    • 100 gloves per sealed inner PE bag,
    • 1 inner PE bag per sealed outer PE bag,
    • 10 outer bags per lined carton (1000 pieces)

    • Preparing equipment for autoclave
    • Weighing and measuring ingredients
    • Cleaning of equipment

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 6.3 - 8.3kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.5 - 6.5kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 32
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 40

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 6.3 - 8.3kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.5 - 6.5kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60
     

    300mm (12″) Non-sterile nitrile Cleanroom gloves

    The Isofield NS300 300mm (12″) non-sterile nitrile Cleanroom glove is ideal for ISO Class 4 cleanrooms and above. Triple washed in deionized water, the ultra-clean NS300 is accelerator free, has low endotoxin, and is smooth enough for double donning whilst also offering a textured palm and fingers for added grip.

    , Details
  • Cleanroom gloves
    Cleanroom gloves with a decorative backgroundCleanroom gloves in a box with a decorative background

    Isofield NS400

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • Non-sterile nitrile Cleanroom gloves
    • 400mm (16”) elbow length
    • Ambidextrous
    • White colour
    • Textured palm and fingers
    • Beaded cuff
    • Low endotoxin levels
    • Tested against a range of chemotherapy drugs
    • Complies with EU food grade Regulation (EU) No 10/2011

    • ISO Class 5 cleanroom
    • ISO Class 4 cleanroom
    • Class 10 cleanroom
    • Class 100 cleanroom

    Manufactured in a facility operating under ISO 9001 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom Physical properties comply with European medical glove standard EN455-2:2015

    20340

    Small 20340S
    Medium 20340M
    Large 20340L
    XLarge 20340XL
    XXLarge 20340XXL

    • Shelf Life:
    • Three (3) years from date of manufacture
    • Storage:
    • Store in a dry, cool place (<40°C) away from direct sunlight
    • Do not expose open cartons to prolonged direct fluorescent light

    • 100 gloves per sealed inner PE bag,
    • 1 inner PE bag per sealed outer PE bag,
    • 10 outer bags per lined carton (1000 pieces)

    • Handling of components before and after washing
    • Transportation and loading of  vials
    • Preparation of ointments and creams before filling

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 11.3 - 14.9kg
    Carton Size W28 L43 H31cm
    Nett Weight 9.3 - 12.9kg
    Air Freight Pallet
    Max height: 139cm
    Layers: 4
    Cartons: 24
    Sea Freight Pallet
    Max height: 170cm
    Layers: 5
    Cartons: 30

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 11.3 - 14.9kg
    Carton Size W28 L43 H31cm
    Nett Weight 9.3 - 12.9kg
    Air Freight Pallet
    Max height: 170cm
    Layers: 5
    Cartons: 40
    Sea Freight Pallet
    Max height: 170cm
    Layers: 5
    Cartons: 40

    400mm (16″) Non-sterile nitrile Cleanroom gloves

    The Isofield NS400 400mm(16″) non-sterile nitrile extended cuff offers excellent elbow length protection for ISO class 4 cleanrooms and above. Triple washed in deionized water, the ultra-clean, food grade NS400 is Chemotherapy tested to ASTM D 6978-05, has low endotoxin and is smooth enough for double donning whilst also offering a textured palm & fingers for added grip.

    , Details
  • Sterile latex Cleanroom gloves with a decorative background
    cleanroom gloves being usedCleanroom Sterile nitrile gloves in a box

    Isofield CRN+

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • Sterile nitrile Cleanroom gloves
    • 400mm (16”) elbow length
    • Ambidextrous
    • White colour
    • Textured palm & fingers
    • Beaded cuff
    • Low endotoxin levels
    • Gamma irradiation, minimum 25kGy
    • Sterility Assurance Level 10-6
    • Tested against a range of chemotherapy drugs
    • Complies with EU food-grade Regulation (EU) No 10/2011
    • IPA resistant ink pouches

    • GMP Grade A cleanroom
    • GMP Grade B cleanroom
    • ISO Class 4 cleanroom
    • ISO Class 5 cleanroom
    • Class 10 cleanroom
    • Class 100 cleanroom

    Manufactured in a facility operating under ISO 9001 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom Physical properties comply with European medical glove standard EN455-2:2015 Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

    20240

    Small 6.0-6.5 20240S
    Medium 7.0-7.5 20240M
    Large 8.0-8.5 20240L
    XLarge 9.0 20240XL

    • Shelf Life 
    • Three (3) years from date of manufacture
    • Storage
    • Store in a dry, cool place (<40°C) away from direct sunlight
    • Do not expose open cartons to prolonged direct fluorescent light

    • 1 pair per inner PE wallet,
    • 1 PE wallet per sealed PE pouch,
    • 10 pouches per PE bag,
    • 20 sealed PE bags per lined carton (200 pairs)

    • Manufacture of sterile liquid and lyophilized vials
    • Filtration, filling, stoppering and capping of vials
    • Aseptic compounding and mixing
    • Preparation of sterile emulsions

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 7.46 - 8.48kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.96 - 5.98kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 32
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 40

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 7.46 - 8.48kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.96 - 5.98kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60

    400mm (16″) Sterile nitrile Cleanroom gloves

    The Isofield CRN+ 400mm (16″) sterile nitrile extended cuff Cleanroom glove offers excellent elbow length protection for GMP Grade A & B, ISO Class 4 cleanrooms and above. Triple washed in deionized water the low endotoxin CRN+ has been tested for chemotherapy against ASTMD 6978-05, is anti-static, and double -donnable.

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  • cleanroom gloves on a decorative background
    writing with cleanroom gloves oncleanroom Sterile nitrile gloves in a box

    Isofield Volta

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • Sterile nitrile Cleanroom gloves
    • 300mm (12”) length
    • Hand-specific
    • Neon green colour
    • Textured fingers
    • Beaded cuff
    • Low endotoxin levels
    • Low endotoxin levels
    • Gamma irradiation, minimum 25kGy
    • Sterility Assurance Level 10-6
    • Accelerator free
    • Tested against a range of chemotherapy drugs
    • IPA resistant ink pouches

    • GMP Grade A cleanroom
    • GMP Grade B cleanroom
    • ISO Class 4 cleanroom
    • ISO Class 5 cleanroom
    • Class 10 cleanroom
    • Class 100 cleanroom

    Manufactured in a facility operating under ISO 9001 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom Physical properties comply with European medical glove standard EN455-2:2015 Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

    20530

    Size 6.0 2053060
    Size 6.5 2053065
    Size 7.0 2053070
    Size 7.5 2053075
    Size 8.0 2053080
    Size 8.5 2053085
    Size 9.0 2053090
    Size 10.0 20530100

    • Shelf Life 
    • Three (3) years from date of manufacture
    • Storage
    • Store in a dry, cool place (<40°C) away from direct sunlight
    • Do not expose open cartons to prolonged direct fluorescent light

    • 1 pair per inner PE wallet,
    • 1 PE wallet per sealed PE pouch,
    • 10 pouches per PE bag,
    • 20 sealed PE bags per lined carton (200 pairs)

    • Manufacture of sterile liquid and lyophilized vials
    • Filtration, filling, stoppering and capping of vials
    • Aseptic compounding and mixing
    • Preparation of sterile emulsions

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 4.77 - 6.41kg
    Carton Size W28 L32 H30cm
    Nett Weight 2.27 - 3.91kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 32
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 40

    Standard Pallet

    Pallet Size W180 L120cm
    Gross Weight 4.77 - 6.41kg
    Carton Size W28 L32 H30cm
    Nett Weight 2.27 - 3.91kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60

    300mm (12″) Sterile nitrile Cleanroom gloves

    The Isofield Volta 300mm (12″) sterile green nitrile Cleanroom gloves offers excellent protection for GMP Grade A & B, ISO Class 4 cleanrooms and above. Perfect as an under glove, and made from accelerator free nitrile, the anti-static Isofield Volta is triple washed in deionized water, has low endotoxin levels and has been tested for chemotherapy against ASTM D 6978-05.

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  • person wearing cleanroom gloves on a decorative background
    Cleanroom gloves on a decorative backgroundwriting with cleanroom gloves onCleanroom Sterile nitrile gloves in a box

    Isofield Eclipse

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • Sterile nitrile Cleanroom gloves
    • 400mm (16”) elbow length
    • Hand-specific
    • White colour
    • Textured palm & fingers
    • Beaded cuff
    • Low endotoxin
    • Gamma irradiation, minimum 25kGy
    • Sterility Assurance Level 10-6
    • Tested against a range of chemotherapy drugs
    • IPA resistant ink pouches

    • GMP Grade A cleanroom
    • GMP Grade B cleanroom
    • ISO Class 4 cleanroom
    • ISO Class 5 cleanroom
    • Class 10 cleanroom
    • Class 100 cleanroom

    Manufactured in a facility operating under ISO 9001 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom Physical properties comply with European medical glove standard EN455-2:2015 Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

    20440

    Size 6.0 2044060
    Size 6.5 2044065
    Size 7.0 2044070
    Size 7.5 2044075
    Size 8.0 2044080
    Size 8.5 2044085
    Size 9.0 2044090
    Size 10.0 20440100

    • Shelf Life 
    • Three (3) years from date of manufacture
    • Storage
    • Store in a dry, cool place (<40°C) away from direct sunlight
    • Do not expose open cartons to prolonged direct fluorescent light

    • 1 pair per inner PE wallet,
    • 1 PE wallet per sealed PE pouch,
    • 10 pouches per PE bag,
    • 20 sealed PE bags per lined carton (200 pairs)

    • Aseptic assembly of filling equipment
    • Filtration, filling, stoppering and capping of vials
    • Aseptic compounding and mixing
    • Staging and conveying of sterile primary packaging components

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 7.6 - 8.3kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.8 - 5.5kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 32
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 40

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 7.6 - 8.3kg
    Carton Size W28 L32 H30cm
    Nett Weight 4.8 - 5.5kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60

    400mm (16”) Sterile nitrile Cleanroom gloves – Hand-specific

    The Isofield Eclipse 400mm (16″) sterile nitrile extended cuff Cleanroom glove with Arm-Lock technology offers excellent elbow length protection for GMP Grade A & B, ISO Class 4 cleanrooms and above. Triple washed in deionized water, the low endotoxin Isofield Eclipse has been tested for chemotherapy against ASTM D 6978-05, is accelerator free and anti-static.

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  • Cleanroom socks with a decorative background
    Cleanroom socks with a decorative backgroundCleanroom socks in a box with a decorative background

    Isofield Cos

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    CERTIFICATE FINDER

    PRODUCT INFO

    • Non-sterile lightweight Cleanroom socks
    • 95% polyester, 5% spandex
    • Mid-calf length
    • White colour
    • Three sizes for added flexibility
    • Low linting

    • ISO Class 4 cleanroom
    • ISO Class 5 cleanroom
    • Class 10 cleanroom
    • Class 100 cleanroom

    Manufactured in a facility operating under ISO 9001:2015 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom

    70610

    Small/Medium 70610S - M
    Large/X-Large 70610L - XL
    XXLarge 70610-XXL

    • Shelf Life:
    • Five (5) years from date of manufacture
    • Storage:
    • Store in a dry, cool place (<40°C) away from direct sunlight. Do not expose open cartons to prolonged direct fluorescent light

    • 10 pairs per double bag,
    • 50 sealed outer cleanroom bags per carton,
    • 500 pairs per carton

    • Pharmaceutical product preparation
    • Cleanroom cleaning and preparation
    • Medical device manufacturing
    • Blending operations for biotechnologies
    • Handling of active materials
    • Maintenance of equipment and instruments

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 13.8 - 16.2kg
    Carton Size W40 L44 H55cm
    Nett Weight  12.6 - 15.0kg
    Air Freight Pallet Max Height: 125cm Layers: 2 Cartons: 8
    Sea Freight Pallet Max Height: 128cm Layers: 3 Cartons: 12

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 13.8 - 16.2kg
    Carton Size W40 L44 H55cm
    Nett Weight 12.6 - 15.0kg
    Air Freight Pallet Max Height: 141cm Layers: 2 Cartons: 12
    Sea Freight Pallet Max Height: 162cm Layers: 3 Cartons: 18

    Non-sterile lightweight Cleanroom socks

    The Isofield Cos single-use non-sterile lightweight cleanroom sock is GMP Annex 1 compatible, offering comfort and protection in cleanroom settings. Available in three sizes, the Cos hourglass heel design ensures comfort levels rivaling most reusable alternatives.

    , Details
  • Cleanroom gloves with a decorative background
    Cleanroom gloves in a box with a decorative background

    Isofield Blazer

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • Sterile latex Cleanroom gloves
    • 300mm (12”) length
    • Hand-specific
    • Natural colour
    • Textured palm & fingers
    • Beaded cuff
    • Low endotoxin levels
    • Gamma irradiation, minimum 25kGy
    • Sterility Assurance Level 10-6
    • Protein level less than 50µg/g
    • High grip, high tack
    • IPA resistant ink pouches

    • GMP Grade A cleanroom
    • GMP Grade B cleanroom
    • ISO Class 4 cleanroom
    • ISO Class 5 cleanroom
    • Class 10 cleanroom
    • Class 100 cleanroom

    Manufactured in a facility operating under ISO 9001 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom Physical properties comply with European medical glove standard EN455-2:2015 Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

    10630

    Size 6.0 1063060
    Size 6.5 1063065
    Size 7.0 1063070
    Size 7.5 1063075
    Size 8.0 1063080
    Size 8.5 1063085
    Size 9.0 1063090
    Size 10.0 10630100

    • Shelf Life 
    • Three (3) years from date of manufacture
    • Storage
    • Store in a dry, cool place (<40°C) away from direct sunlight
    • Do not expose open cartons to prolonged direct fluorescent light

    • 1 pair per inner PE wallet,
    • 1 PE wallet per sealed PE pouch,
    • 10 pouches per PE bag,
    • 20 sealed PE bags per lined carton (200 pairs)

    • Aseptic compounding and mixing
    • Preparation of sterile emulsions
    • Manufacture of sterile liquid and lyophilized vials
    • Filtration, filling, stoppering and capping of vials

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 6.14 - 7.46kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.34- 4.66kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 32
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 40

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 6.14 - 7.46kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.34 - 4.66kg
    Air Freight Pallet
    Max height: 135cm
    Layers: 4
    Cartons: 48
    Sea Freight Pallet
    Max height: 165cm
    Layers: 5
    Cartons: 60

    300mm (12”) Sterile latex Cleanroom gloves

    The Isofield Blazer 300mm (12″) sterile latex Cleanroom glove with a thicker cuff is an excellent option for GMP Grade A & B, ISO Class 4 cleanrooms and above. This ultra clean latex glove is triple washed in deionized water and is supplied with a high-tack finish for applications that require extra grip and traction. Every Blazer lot is tested for endotoxin and has very low levels of detectable protein (less than 50 µg/g).

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  • Cleanroom gloves with a decorative background
    Cleanroom gloves in a box with a decorative background

    Isofield Blazer LT

    DATA SHEET
    DECLARATION OF CONFORMITY
    VALIDATION PACK
    DECLARATION OF CONFORMITY
    CERTIFICATE FINDER

    PRODUCT INFO

    • Sterile latex Cleanroom gloves
    • 300mm (12”) length
    • Hand-specific
    • Natural colour
    • Textured palm & fingers
    • Beaded cuff
    • Low endotoxin levels
    • Gamma irradiation, minimum 25kGy
    • Sterility Assurance Level 10-6
    • Protein level less than 50µg/g
    • IPA resistant ink pouches

    • GMP Grade A cleanroom
    • GMP Grade B cleanroom
    • ISO Class 4 cleanroom
    • ISO Class 5 cleanroom
    • Class 10 cleanroom
    • Class 100 cleanroom

    Manufactured in a facility operating under ISO 9001 quality management system Processed in a NEBB certified ISO Class 5 Cleanroom Physical properties comply with European medical glove standard EN455-2:2015 Sterilization: Gamma irradiation, EN ISO 11137 Part 2:2015

    10630LT

    Size 6.0 1063060LT
    Size 6.5 1063065LT
    Size 7.0 1063070LT
    Size 7.5 1063075LT
    Size 8.0 1063080LT
    Size 8.5 1063085LT
    Size 9.0 1063090LT
    Size 10.0 10630100LT

    • Shelf Life 
    • Three (3) years from date of manufacture
    • Storage
    • Store in a dry, cool place (<40°C) away from direct sunlight
    • Do not expose open cartons to prolonged direct fluorescent light

    • 1 pair per inner PE wallet,
    • 1 PE wallet per sealed PE pouch,
    • 10 pouches per PE bag,
    • 20 sealed PE bags per lined carton (200 pairs)

    • Aseptic compounding and mixing
    • Preparation of sterile emulsions
    • Manufacture of sterile liquid and lyophilized vials
    • Filtration, filling, stoppering and capping of vials

    Euro Pallets

    Pallet Size W80 L120cm
    Gross Weight 6.14 - 7.62kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.34 - 4.82 kg
    Air Freight Pallet Max Height: 135cm Layers: 4 Cartons: 32
    Sea Freight Pallet Max Height: 165cm Layers: 5 Cartons: 40

    Standard Pallet

    Pallet Size W100 L120cm
    Gross Weight 6.14 - 7.62kg
    Carton Size W28 L32 H30cm
    Nett Weight 3.34 - 4.82kg
    Air Freight Pallet Max Height: 135cm Layers: 4 Cartons: 48
    Sea Freight Pallet Max Height: 165cm Layers: 5 Cartons: 60

    300mm (12″) Sterile latex Cleanroom gloves

    The Isofield Blazer LT 300mm (12″) sterile latex Cleanroom glove with extended cuff offers excellent elbow length protection for GMP Grade A & B, ISO Class 4 cleanrooms and above. This ultra clean latex glove is triple washed in deionized water and its surface is smooth enough for double-donning whilst also offering a textured palm & fingers for added grip. Every Blazer LT lot is tested for endotoxin and has very low levels of detectable protein (less than 50 µg/g).

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