Intended purpose of use: For wound dressing and general securement of tubing and devices.
Product description:
Components: High adhesion, breathable cloth tape coated with adhesive for a range of applications.
Hypoallergenic and skin friendly. Non irritant and non sensitizing.
Non-stretch.
Can be torn by hand.
Water resistant.
Must adhere strongly when applied to the skin, but can be removed without causing skin trauma, Easy to unroll till the tape core.
Material: Textile strip: woven viscose, cotton of similar.
Adhesive: Rubber based, medical grade.
Traditionally incorporates zinc oxide.
Colour: White of flesh coloured.
Length: approximately 5m.
Width: approximately 10cm.
Non-sterile and single use.
Shelf life to be included.
Hygienically packed for medical use.
Instructions for use:
Adhesive tape used for fixing dressings and general securement of critical tubes and devices to the skin. Select the correct size and type of tape for the application intended. Clip hair, if necessary. Apply the tape without tension to clean, dry skin, gently but firmly stroking the surface to maximize adhesion. When fixing dressings, tape should extend at least one-half inch beyond the edge of the dressing to hold the dressing in place.
Zinc oxide tape has been selected because it is inexpensive.
The quality is difficult to judge and the adhesive can deteriorate seriously under exposure to heat and dampness.
Make sure the storage conditions are observed, so as to obtain maximum use of the item and avoid waste.
The size has been chosen as being the most commonly used. Tape adhesive zinc oxide, perforated, 10 cm x 5 m, for important wound dressing and surgery.
Supplied with:
Manufacturer's instruction for use. Indications for use, contraindications, warnings, storage and disposal instructions shall be provided.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) adhesive tape in a plastic bag.
Secondary packaging: Protected unit.
Ten (10) adhesive tapes in a box.
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 (must comply with latest revision of standards):
ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 29862: Self adhesive tapes — Determination of peel adhesion properties of equivalent.
Complies to USP.
Environmental requirements: ISO 14001.
Product description:
Components: High adhesion, breathable cloth tape coated with adhesive for a range of applications.
Hypoallergenic and skin friendly. Non irritant and non sensitizing.
Non-stretch.
Can be torn by hand.
Water resistant.
Must adhere strongly when applied to the skin, but can be removed without causing skin trauma, Easy to unroll till the tape core.
Material: Textile strip: woven viscose, cotton of similar.
Adhesive: Rubber based, medical grade.
Traditionally incorporates zinc oxide.
Colour: White of flesh coloured.
Length: approximately 5m.
Width: approximately 10cm.
Non-sterile and single use.
Shelf life to be included.
Hygienically packed for medical use.
Instructions for use:
Adhesive tape used for fixing dressings and general securement of critical tubes and devices to the skin. Select the correct size and type of tape for the application intended. Clip hair, if necessary. Apply the tape without tension to clean, dry skin, gently but firmly stroking the surface to maximize adhesion. When fixing dressings, tape should extend at least one-half inch beyond the edge of the dressing to hold the dressing in place.
Zinc oxide tape has been selected because it is inexpensive.
The quality is difficult to judge and the adhesive can deteriorate seriously under exposure to heat and dampness.
Make sure the storage conditions are observed, so as to obtain maximum use of the item and avoid waste.
The size has been chosen as being the most commonly used. Tape adhesive zinc oxide, perforated, 10 cm x 5 m, for important wound dressing and surgery.
Supplied with:
Manufacturer's instruction for use. Indications for use, contraindications, warnings, storage and disposal instructions shall be provided.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) adhesive tape in a plastic bag.
Secondary packaging: Protected unit.
Ten (10) adhesive tapes in a box.
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 (must comply with latest revision of standards):
ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 29862: Self adhesive tapes — Determination of peel adhesion properties of equivalent.
Complies to USP.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.47 |
| Pack of 10 | $14.38 |
| Pack of 12 | $23.40 |
