Gloves,exam,nitrile,pwdfree,L,BOX-100

General Description
Gloves, medical, examination, nitrile, 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
Powder- free
Size: large (8.5 to 9.5)
Thickness at fingertips of min. 0.08 mm
Non-sterile
Single-use

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

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

Regulation & classification:
Medical Device Regulation (EU) 2017/745, Class I
Medical Device Directive 93/42/EEC, Class I
Personal Protective Equipment Regulation (EU) 2016/425, Cat III

Compliance to safety & product performance standards:
EN 455, EN 374

Safety process:
Wash hands before and after use of gloves.
Gloves should not be used if packaging is damaged. Check the integrity of each unit before use. Discard defective or deteriorate gloves.
Wearing and removing gloves should be done according to strict safety dressing procedure.
Ensure that the gloves are correctly used by trained staff.
Removed and replaced damaged gloves while in use.
After use, dispose, collect and destroy through incineration in a controlled environment.

Storage:
Keep the gloves in the original packaging (box), protected from sunlight and humidity.