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

General Description:
Gloves, gynaecological, latex, powder-free, size: small, 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: small (6.5)
Total length: min. 480 mm
Palm width: 80 ±10 mm
Finger thickness: 0.20 ±0.03 mm
External surface: Micro-textured
Cuff: Beaded
Color: cream, white
Single-use
Sterile
Shelf life: 5 years

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 455-1:2020: 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 11135:2014: Sterilization of health-care products. Ethylene oxide or
EN ISO 11137-1:2015+A2:2019: Sterilization of health care products. Radiation.
ISO 11607-1:2007: Packaging for terminally sterilized medical devices.
or equivalent international standards.

Environmental conditions:
Protect from heat and moisture.
Keep in clean and dry places.
Do not use if the packaging is open or damaged.
Do not expose to direct light or ozone.
Store at room temperature.

Packaging and labelling:
Primary packaging: Unit of use
One (1) pair of gloves in an individual sterilised peel pack.
Supplied with double packaging: one interior layer plus sterilised 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.

Secondary packaging: Protected unit.
One (1) box of 50 pairs of gloves.