IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: used by healthcare workers to scrub their hands, fingers, and forearms prior to surgery of other intervention where a high degree of personal hygiene is required
Product description:
To be used for scrubbing hand prior to surgical intervention.
Brush, nylon bristles, plastic block.
Soft bristles: Minimum 5 rows.
Material:
- Head: Polypropylene.
- Bristles: Nylon.
Dimension:
Length: head approx. 8 - 10 cm.
Width: approx. 3 - 5 cm.
Height: approx. 1 cm.
Reusable, can be sterilized by autoclave
Non-sterile
Instructions for use:
Plastic brush for scrubbing hands in general, and specifically prior to surgery.
This brush must be a plastic type that can be autoclaved after cleaning and disinfection.
Do not use a brush with wooden head as cracks in the wood may harbour contamination.
The size has been chosen as being the most commonly used.
Safety process:
This item is used as a «clean» of «sterile» item.
The item must be cleaned, disinfected and sterilized in a steam
sterilizer as often as necessary.
Protection of users:
Washing hands before and after each medical act is extremely important to limit the risk of cross-contamination. Wash hands as often as necessary.
Prior to any medical act: Use water and soap. Time approx. 3 minutes.
Prior to surgical purpose: Use distilled water and soap of disinfectant. Time approx. 8 minutes.
Supplied with:
Manufacturer's instruction for use. to provide cleaning, disinfection before autoclave.
Packaging and labelling:
One ( 1) of two (2) scrubbing brush in a plastic bag with manufacturer's instruction for user in English. Alternatively, the instruction for use can be indicated on a separate insert.
Secondary packaging: Protected unit
Ten (10) scrubbing brushes in a box with manufacturer's instruction for use (when applicable).
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Symbols used according ISO 15223
Secondary packaging:
Ten (10) scrubbing brushes in a box with manufacturer's instruction for use (when applicable).
Labelling on the secondary packaging:
Name and/of trademark and address of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Number of units per secondary packaging.
Information for particular storage conditions(temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Information for handling, if applicable(of equivalent harmonised symbol).
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:
NA
Safety & product Standards:
Must comply with the following standards:
ISO 9001
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended purpose of use: used by healthcare workers to scrub their hands, fingers, and forearms prior to surgery of other intervention where a high degree of personal hygiene is required
Product description:
To be used for scrubbing hand prior to surgical intervention.
Brush, nylon bristles, plastic block.
Soft bristles: Minimum 5 rows.
Material:
- Head: Polypropylene.
- Bristles: Nylon.
Dimension:
Length: head approx. 8 - 10 cm.
Width: approx. 3 - 5 cm.
Height: approx. 1 cm.
Reusable, can be sterilized by autoclave
Non-sterile
Instructions for use:
Plastic brush for scrubbing hands in general, and specifically prior to surgery.
This brush must be a plastic type that can be autoclaved after cleaning and disinfection.
Do not use a brush with wooden head as cracks in the wood may harbour contamination.
The size has been chosen as being the most commonly used.
Safety process:
This item is used as a «clean» of «sterile» item.
The item must be cleaned, disinfected and sterilized in a steam
sterilizer as often as necessary.
Protection of users:
Washing hands before and after each medical act is extremely important to limit the risk of cross-contamination. Wash hands as often as necessary.
Prior to any medical act: Use water and soap. Time approx. 3 minutes.
Prior to surgical purpose: Use distilled water and soap of disinfectant. Time approx. 8 minutes.
Supplied with:
Manufacturer's instruction for use. to provide cleaning, disinfection before autoclave.
Packaging and labelling:
One ( 1) of two (2) scrubbing brush in a plastic bag with manufacturer's instruction for user in English. Alternatively, the instruction for use can be indicated on a separate insert.
Secondary packaging: Protected unit
Ten (10) scrubbing brushes in a box with manufacturer's instruction for use (when applicable).
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Symbols used according ISO 15223
Secondary packaging:
Ten (10) scrubbing brushes in a box with manufacturer's instruction for use (when applicable).
Labelling on the secondary packaging:
Name and/of trademark and address of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Number of units per secondary packaging.
Information for particular storage conditions(temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Information for handling, if applicable(of equivalent harmonised symbol).
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:
NA
Safety & product Standards:
Must comply with the following standards:
ISO 9001
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.85 |
