IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: Apron to be used in healthcare facilities by personnel performing medical/obstetrical/surgical procedures with high risk of contamination by body fluids projection.
Product description:
Protective apron to be worn by surgeon of midwife for protection.
Straight apron with bib, back fastening and neckband, should be strong and not detachable.
Moisture-proof and blood, water, chemical and stain resistant.
Material: Opaque of translucent high quality plastic material withstanding washing, boiling, steam sterilization, resistant to 0.5% chlorine.
Size: Adult size.
Length: 120cm (+/- 5cm from top of the bib to lower edge of the apron).
Total length: 145 cm (+/-5cm)
Width: 80cm (+/-10cm).
Thickness: 0.15 - 0.30mm.
Non-sterile and reusable.
Instructions for use:
Apron to be used in healthcare facilities by personnel performing medical / obstetrical / surgical procedures with high risk of contamination by body fluids projection.
The size has been chosen as the most commonly used.
After use, the apron must be washed, disinfected with chlorine solution (0.05% concentration) and dried.
If the apron is damaged (perforation, etc.), it must be disposed in waste container, collected and destroyed. Please refer to WHO publication ""Safe management of waste for Health Care"".
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Individually packaged in a transparent plastic bag.
Labelling of the primary packaging displays, at least: Product name, size, reference number, manufacturer's name and address, CE mark of similar, lot number of batch number, UDI (if MDR certified), use-by-date, symbol for Medical device
The words “Non-sterile, reusable"" (of equivalent harmonised symbol).
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol), if applicable.
Symbols used according ISO 15223
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 following standards
ISO 22610 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration
ISO 22612 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: Apron to be used in healthcare facilities by personnel performing medical/obstetrical/surgical procedures with high risk of contamination by body fluids projection.
Product description:
Protective apron to be worn by surgeon of midwife for protection.
Straight apron with bib, back fastening and neckband, should be strong and not detachable.
Moisture-proof and blood, water, chemical and stain resistant.
Material: Opaque of translucent high quality plastic material withstanding washing, boiling, steam sterilization, resistant to 0.5% chlorine.
Size: Adult size.
Length: 120cm (+/- 5cm from top of the bib to lower edge of the apron).
Total length: 145 cm (+/-5cm)
Width: 80cm (+/-10cm).
Thickness: 0.15 - 0.30mm.
Non-sterile and reusable.
Instructions for use:
Apron to be used in healthcare facilities by personnel performing medical / obstetrical / surgical procedures with high risk of contamination by body fluids projection.
The size has been chosen as the most commonly used.
After use, the apron must be washed, disinfected with chlorine solution (0.05% concentration) and dried.
If the apron is damaged (perforation, etc.), it must be disposed in waste container, collected and destroyed. Please refer to WHO publication ""Safe management of waste for Health Care"".
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Individually packaged in a transparent plastic bag.
Labelling of the primary packaging displays, at least: Product name, size, reference number, manufacturer's name and address, CE mark of similar, lot number of batch number, UDI (if MDR certified), use-by-date, symbol for Medical device
The words “Non-sterile, reusable"" (of equivalent harmonised symbol).
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol), if applicable.
Symbols used according ISO 15223
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 following standards
ISO 22610 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration
ISO 22612 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $2.00 |
