Intended purpose of use : For uses such as disinfection of skin, cleaning wounds, Used as wound dressing when sterilized
Product description: A non-medicated, dressing item in the form of a patch (also referred to as a sponge) made from woven material and primarily designed to absorb fluids for medical purposes.
Gauze compress, surgical folding, i.e. no free threads apparent after folding of when the first outside fold is opened.
Material: Absorbent gauze, 100% cotton, medical grade
Components: Bleached, purified textile, plain weave.
Not detectable by X-ray.
Steam sterilization recommended.
Shel life
Thread count warp: 95 to 105 threads/dm, weft 66 to 74 threads/dm.
Weight: 23g/m2.
Type of gauze: 17 threads/cm2 (grammage 23g/m2).
Number of folds (thickness): 12.
Width: approx. 10cm.
Length: approx. 10cm.
Non-sterile and single use.
Hygienically packed for medical use.
Instructions for use:
Dressing material used for cleaning wounds, disinfecting healthy skin, protecting wounds, etc; non-sterile gauze compress of 17 threads and 12
folds has been selected as it can also be used for surgery in sterile condition (after steam sterilisation).
The size has been chosen as being the most commonly used
Shall include storage conditions, disposal instructions etc.
Supplied with:
Manufacturer's instruction for use. Multilingual
Packaging and labelling:
Primary packaging: Unit of use.
One (1) plastic of paper pack of 100 compresses
gauze bandages in a plastic bag.
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:
Must comply with the following standards (as per the latest revisions of the standards):
BS EN 14079 Non-active medical devices. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze of as per pharmacopoeia specifications for bleached cotton gauze
EN 13726-1 Test methods for primary wound dressings - Part 1: Aspects of absorbency
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing. You should select the tests appropriate for the duration and level of contact.
Product description: A non-medicated, dressing item in the form of a patch (also referred to as a sponge) made from woven material and primarily designed to absorb fluids for medical purposes.
Gauze compress, surgical folding, i.e. no free threads apparent after folding of when the first outside fold is opened.
Material: Absorbent gauze, 100% cotton, medical grade
Components: Bleached, purified textile, plain weave.
Not detectable by X-ray.
Steam sterilization recommended.
Shel life
Thread count warp: 95 to 105 threads/dm, weft 66 to 74 threads/dm.
Weight: 23g/m2.
Type of gauze: 17 threads/cm2 (grammage 23g/m2).
Number of folds (thickness): 12.
Width: approx. 10cm.
Length: approx. 10cm.
Non-sterile and single use.
Hygienically packed for medical use.
Instructions for use:
Dressing material used for cleaning wounds, disinfecting healthy skin, protecting wounds, etc; non-sterile gauze compress of 17 threads and 12
folds has been selected as it can also be used for surgery in sterile condition (after steam sterilisation).
The size has been chosen as being the most commonly used
Shall include storage conditions, disposal instructions etc.
Supplied with:
Manufacturer's instruction for use. Multilingual
Packaging and labelling:
Primary packaging: Unit of use.
One (1) plastic of paper pack of 100 compresses
gauze bandages in a plastic bag.
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:
Must comply with the following standards (as per the latest revisions of the standards):
BS EN 14079 Non-active medical devices. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze of as per pharmacopoeia specifications for bleached cotton gauze
EN 13726-1 Test methods for primary wound dressings - Part 1: Aspects of absorbency
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing. You should select the tests appropriate for the duration and level of contact.
| Pack Size | Avg. Price |
|---|---|
| Pack of 5 | $0.23 |
| Pack of 20 | $1.08 |
| Pack of 50 | $2.33 |
| Pack of 100 | $3.26 |
