Intended purpose of use: gloves intended for use in the medical field to protect patient and user from cross-contamination.
Product description:
Glove for clinical examinations and routine clinical laboratory work contains of 5 fingers, palm and a sleeve
Ambidextrous (Fits either hand).
Material: Natural rubber latex.
Waterproof.
Non-sterile.
Single-use disposable.
Powder Free.
Size: small.
Total length: minimum 240mm.
Width: 80 mm, +/- 10mm.
Thickness: fingers: 0.12mm; palm: 0.1mm.
AQL for holes = 1.5 (water tightness test).
Low residual extractable protein level.
Shelf life to be indicated.
Instructions for use:
Used for multiple purposes.
Used in wide range of laboratory services from basic laboratory to reference centre.
Supplied with:
Manufacturer's instruction for use.
Use instructions, warnings, storage conditions, disposal instructions etc.
Packaging and labelling: shall be as per regulations applicable to the device.
Unit presentation: Unit presentation: 1(one) Gloves, exam, latex, small, disp, box/100.
Symbols used according ISO 15223.
CE Mark.
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 I 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 21171:2006 Medical gloves - Determination of removable surface powder.
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.
Product description:
Glove for clinical examinations and routine clinical laboratory work contains of 5 fingers, palm and a sleeve
Ambidextrous (Fits either hand).
Material: Natural rubber latex.
Waterproof.
Non-sterile.
Single-use disposable.
Powder Free.
Size: small.
Total length: minimum 240mm.
Width: 80 mm, +/- 10mm.
Thickness: fingers: 0.12mm; palm: 0.1mm.
AQL for holes = 1.5 (water tightness test).
Low residual extractable protein level.
Shelf life to be indicated.
Instructions for use:
Used for multiple purposes.
Used in wide range of laboratory services from basic laboratory to reference centre.
Supplied with:
Manufacturer's instruction for use.
Use instructions, warnings, storage conditions, disposal instructions etc.
Packaging and labelling: shall be as per regulations applicable to the device.
Unit presentation: Unit presentation: 1(one) Gloves, exam, latex, small, disp, box/100.
Symbols used according ISO 15223.
CE Mark.
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 I 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 21171:2006 Medical gloves - Determination of removable surface powder.
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.
| Pack Size | Avg. Price |
|---|---|
| Pack of 100 | $4.25 |
