Gloves,gyn,pwdfree,large,ster,s.u.,pair

General Description:
Gloves, gynaecological, latex, powder-free, size: large, sterile, single use, pair.
Synonym: Long cuff gloves.

Intended use:
Long cuff gloves for gynaecological and obstetric procedures to protect both patient and medical staff from cross-contamination. Gynaecological gloves are sterile and strictly SINGLE USE.

Technical Specifications:
Pair of gynaecological gloves with long cuff
Anatomically shaped: 1 right-handed, 1 left-handed
Material: Natural latex
Powder-free
Size: large (8.5-9)
Total length: approx. 400 mm. (400 - 480 mm)
Palm width: approx. 108 +/- 5 mm
Single-use
Sterile

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

Regulation & classification:
Medical Device Directive 93/42/EEC, Class IIa

Compliance to safety & product performance standards:
EN 455 part 1-4

Packaging and labelling:
Primary packaging: Unit of use
One (1) pair of gloves in an individual sterilized peel pack
Supplied with double packaging: one interior layer plus sterilized peel-pack.
Packed in the interior layer: right and left hand with the sleeves reversed up to the thumb.
Labelled with: size, right hand, left hand and position of the sleeves.

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.

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