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: small (6.5-7).
Total length: approximately 400mm.
Palm width: approximately 83±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: small (6.5-7).
Total length: approximately 400mm.
Palm width: approximately 83±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 | $39.34 |
| Pack of 25 | $41.88 |
