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

General Description:
Gloves, medical, examination, latex, 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. 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: large
Total length: approx. 230 mm
Palm width: approx. 110 + or - 10 mm
Thickness at fingertips of ≥ 0.08 mm
Single-use
Non sterile

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

Compliance to safety & product performance standards:
EN 455

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.

Component of a kit:
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