Surgical Glove, Sterile Polyisoprene - GloveOn Victor

Unit: Package

Quantity per unit: 50

Material: Sterile polyisoprene

Powder: No (powder-free)

Sterile: Yes

Shelf life: 5 years

Specifications: AQL 0.65, gamma-sterilized, anatomically curved fingers, hand-specific fit (right and left), microtextured, 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, collar (mm): 0.15 ±0.04

Length (mm): 290 ±10

Tensile strength, before aging (MPa): ≥17

Tensile strength, after aging (MPa): ≥12

Elongation at break, pre-aging (%): ≥650

Elongation at break, after aging (%): ≥490

Median breaking force (N): ≥9

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

Quantity:

• 50 pairs (right and left) per package

• 4 packs per box (200 pairs)

• 192 packages per pallet (9,600 pairs)

Dimensions:

• Packaging: 162 x 132 x 287 mm

• Box: 334 x 274 x 297 mm

• Stool: 120 x 80 x 193 cm

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)