Glove Construction and Features

• Material: 100% nitrile (latex-free, accelerator-safe or free preferred)
• Colour: Blue
• Finish: Textured fingertips for grip
• Fit: Ambidextrous
• Cuff: Beaded
• Powder: Powder-free (residual powder ≤2 mg/glove)

Dimensions and Strength

• Thickness (min): 0.10 mm (fingertip), 0.07 mm (palm), 0.05 mm (cuff)
• Length (min): 240 mm
• Tensile Strength: ≥14 MPa (before aging), ≥6 N force at break (after aging)
• Elongation: ≥500% before aging, ≥400% after aging

Protection Performance

• AQL: ≤1.5 for pinholes (EN 455-1)
• EN ISO 374-5: Viral and microorganism protection
• EN ISO 374-1: Type B or better chemical resistance

Biocompatibility and Safety

• ISO 10993-5 & 10993-10: Non-cytotoxic, non-irritant, non-sensitising
• ISO 21171: ≤2 mg residual powder
• Absence of latex proteins and common skin allergens

Packaging and Labelling

• Inner: 100 gloves/box; Outer: 10 boxes/carton
• Markings: CE mark, EN standards, lot number, expiry date, glove size
• Label Language: English (multilingual optional)
• Expiry: ≥3 years (preferably 5)
• Storage: 5°C–40°C; cool, dry, light-protected area

Regulatory and Standard Compliance

• CE marking with Notified Body number
• PPE Regulation (EU) 2016/425 – Category III PPE
• MDR (EU) 2017/745 – Class I Medical Device
• EN 455 (Parts 1–4): Medical gloves for single use
• EN ISO 374 (Parts 1, 2, 4, 5): Chemical and micro-organism protection
• EN ISO 21420:2020: General glove requirements

Application:

Food Industry (restaurants, catering, food processing facilities)
Healthcare (hospitals, medical labs, nursing homes)
Automotive Industry (mechanics, production lines)
Chemical Facilities (production, manufacturing)
Cleaning Industry (home, commercial)