Intended purpose of use: to be worn on the hands in surgical settings for Gynaecological use, provide a barrier against potentially infectious material and other contaminants.
Product description: Long cuff gloves.
Pair of gynaecological gloves with long cuff, anatomically shaped: 1 right-handed, 1 left-handed.
Waterproof.
Stretch proof.
Material: Natural latex.
Powder-free.
Size selected: Gynaecological gloves, size: large (8.5-9).
Total length: 400mm.
Width: 108±5 mm.
Thickness: cuff minimum 0.12mm; palm minimum 0.16mm; fingers minimum 0.18mm.
Sterile and single use.
AQL for holes = 0.65 (water tightness test).
Low residual extractable protein level.
Shelf life to be indicated.
Initial sterilisation method: Ethylene oxide gas of Gamma radiation.
Instructions for use:
Sterile single use gloves with long cuff used for gynaecological and obstetric procedures to protect both patient and medical staff from cross-contamination.
Gynaecological gloves, also named long cuff gloves are sterile and strictly SINGLE USE.
This item must be ordered in sufficient quantity to encourage its use.
The sizes have been chosen as being the most commonly used.
Supplied with:
Manufacturer's instruction for use. Use instructions, warnings, storage conditions, disposal instructions etc.
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 25 of 50 pairs gloves.
Symbols used according ISO 15223.
CE Mark with Notified Body number.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class IIa device.
Safety & product Standards (all submissions must be as per latest revisions of standards):
Must comply with the following applicable standards of equivalent ensuring conformance to the latest revisions.
BS EN 455-1:2020 Medical gloves for single use. Requirements and testing for freedom from holes.
BS EN 455-2:2015 Medical gloves for single use. Requirements and testing for physical properties.
BS EN 455-3:2015 Medical gloves for single use. Requirements and testing for biological evaluation.
BS EN 455-4:2009 Medical gloves for single use. Requirements and testing for shelf life determination.
ISO 12243:2003 Medical gloves made from natural rubber latex -- Determination of water-extractable protein using the modified Lowry method of ASTM D 5712.
ISO 2859-1 – Sampling procedures.
ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
ISO 11607-1&2 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
Product description: Long cuff gloves.
Pair of gynaecological gloves with long cuff, anatomically shaped: 1 right-handed, 1 left-handed.
Waterproof.
Stretch proof.
Material: Natural latex.
Powder-free.
Size selected: Gynaecological gloves, size: large (8.5-9).
Total length: 400mm.
Width: 108±5 mm.
Thickness: cuff minimum 0.12mm; palm minimum 0.16mm; fingers minimum 0.18mm.
Sterile and single use.
AQL for holes = 0.65 (water tightness test).
Low residual extractable protein level.
Shelf life to be indicated.
Initial sterilisation method: Ethylene oxide gas of Gamma radiation.
Instructions for use:
Sterile single use gloves with long cuff used for gynaecological and obstetric procedures to protect both patient and medical staff from cross-contamination.
Gynaecological gloves, also named long cuff gloves are sterile and strictly SINGLE USE.
This item must be ordered in sufficient quantity to encourage its use.
The sizes have been chosen as being the most commonly used.
Supplied with:
Manufacturer's instruction for use. Use instructions, warnings, storage conditions, disposal instructions etc.
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 25 of 50 pairs gloves.
Symbols used according ISO 15223.
CE Mark with Notified Body number.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class IIa device.
Safety & product Standards (all submissions must be as per latest revisions of standards):
Must comply with the following applicable standards of equivalent ensuring conformance to the latest revisions.
BS EN 455-1:2020 Medical gloves for single use. Requirements and testing for freedom from holes.
BS EN 455-2:2015 Medical gloves for single use. Requirements and testing for physical properties.
BS EN 455-3:2015 Medical gloves for single use. Requirements and testing for biological evaluation.
BS EN 455-4:2009 Medical gloves for single use. Requirements and testing for shelf life determination.
ISO 12243:2003 Medical gloves made from natural rubber latex -- Determination of water-extractable protein using the modified Lowry method of ASTM D 5712.
ISO 2859-1 – Sampling procedures.
ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
ISO 11607-1&2 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.15 |
| Pack of 50 | $21.17 |
| Pack of 25 | $41.88 |
