Gloves,exam,nitrile,BIO,pwdfree,L,BOX100

General Description
Gloves, medical, examination, nitrile, biodegradable, powder-free, size: large, single use, box of 100

Intended use:
Medical examination gloves used for medical procedures to protect both patient and medical staff from cross-contamination. Nitrile examination gloves provides protection from chemicals and micro-organisms. Non-sterile and strictly SINGLE USE.

Technical Specifications
Medical examination glove
Ambidextrous shape: fits either hand
Material: nitrile
Biodegradable
Powder- free
Size: large
Total length: min. 240 mm
Palm width: 105 ± 3 mm
Thickness at fingertips: 0.09 ±0.02 mm
Non-sterile
Single-use
Shelf life: 3 years
Biodegradability: 3-5 years

Environmental conditions:
Operating conditions: 10-30 ˚C.
Store in a cool dry place, relative humidity ≤ 80%, avoid direct sunlight.

Packaging and labelling:
Primary packaging: Unit of use
One (1) box of 100 gloves

Secondary packaging:
10 boxes per carton

Quality Management System:
ISO 13485:2016: Medical devices - Quality management systems

Regulation & classification:
Medical Device Regulation (EU) 2017/745, Class I
Personal Protective Equipment Regulation (EU) 2016/425, Cat III

Compliance to safety & product performance standards:
EN 455-1:2020: Medical gloves for single use. Requirements and testing for freedom from holes.
EN 455-2:2015: Medical gloves for single use. Requirements and testing for physical properties.
EN 455-3:2015: Medical gloves for single use. Requirements and testing for biological evaluation.
EN 455-4:2009: Medical gloves for single use. Requirements and testing for shelf life determination.
EN ISO 374-1:2016+A1:2018: Protective gloves against dangerous chemicals and micro-organisms.
EN ISO 374-5:2016: Protective gloves against dangerous chemicals and micro-organisms.
EN 420:2003+A1:2009 / EN ISO 21420:2020 Protective gloves. General requirements and test methods.