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Unit: Package
Quantity per unit: 50
Material: Sterile polyisoprene
Powder: No (powder-free)
Sterile: Yes
Shelf life: 5 years
Specifications: AQL 0.65, sterilised using gamma irradiation, Anatomically curved fingers, hand-specific fit (right and left), micro-textured, powder-free, latex-free
Color: Natural white
Sizes: (5.5–8.5)
Thickness, fingers (mm): 0.21 ±0.04
Thickness, palm (mm): 0.19 ±0.04
Thickness, cuff (mm): 0.15 ±0.04
Length (mm): 290 ±10
Tensile strength, before aging (MPa): ≥17
Tensile strength, after aging (MPa): ≥12
Elongation, before aging (%): ≥650
Elongation, after aging (%): ≥490
Median breaking force (N): ≥9
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Applicable standards:
• PPE Regulation (EU) 2016/425, Category III
• MDR Regulation (EU) 2017/745, Class IIa
• EN 374-1, 2, 4, 5
• EN 16523-1
• EN 21420
- EN 455-1,2,3,4
• ASTM D3577
- ASTM D5151
• ASTM D6124
• ASTM D6978
- ASTM F1671
Accreditation and quality certificates:
• ISO 10282
• ISO 11137
• ISO 10993-5, 10, 11, 23
- ISO 9001
- ISO 13485
Manufacturer: Hartalega NGC Sdn Bhd
CE Certificates: CE 2777 (PPE), CE 0123 (MDR)
Notified Body (PPE): SATRA Technology Europe Ltd, NB No. 2777
Notified Body (MDR): TÜV SÜD Product Service GmbH, NB No. 0123
MDA Registration No.: GB3133124-173535
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Quantity:
• 50 pairs (right and left) per box
• 4 packs per boxes/carton (200 pairs)
• 192 packages per boxes/pallet (9,600 pairs)
Measurements:• Box: 162 x 132 x 287 mm
•Carton: 334 x 274 x 297 mm
• Pallet: 120 x 80 x 193 cm
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Item number:
• SPI2855 (5.5)
• SPI2860 (6.0)
• SPI2865 (6.5)
• SPI2870 (7.0)
• SPI2875 (7.5)
• SPI2880 (8.0)
• SPI2885 (8.5)
EAN packaging:
• (5.5)
• 9332347006584 (6.0)• 9332347006591 (6.5)
• 9332347006607 (7.0)
• 9332347006614 (7.5)
• 9332347006621 (8.0)
• (8.5)

