Gloves,exam,latex,pwdfree,M,BOX-100

General Description:
Gloves, medical, examination, latex, powder-free, size: medium, single use, box of 100.

Intended use:
Medical examination gloves used for medical procedures to protect both patient and medical staff from cross-contamination. Examination gloves are non-sterile and strictly SINGLE USE.

Technical Specifications:
Medical examination glove
Ambidextrous shape: fits either hand
Material: Natural latex
Powder-free
Size: medium
Total length: min. 240 mm
Palm width: 95 +/- 10 mm
Thickness at fingertips: min. 0.11 mm +/- 0.02 mm
Single-use
Non sterile
Shelf life: 5 years

Environmental conditions:
Transport and storage conditions: Protected from light, humidity and at a temperature between 5 and 40 °C.

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

Secondary packaging:
10 boxes of 100 gloves

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 420:2003+A1:2009 / EN ISO 21420:2020 Protective gloves. General requirements and test methods.
EN ISO 374-1:2016+A1:2018 Protective gloves against dangerous chemicals and micro-organisms. Terminology and performance requirements for chemical risks.
EN ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms. Terminology and performance requirements for micro-organisms risks.
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