IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected supplier.
Product description:
Apron, disposable, non sterile
This is a disposable, single use garment that must be disposed after one time use.
Intended purpose of use: A garment designed to be worn by medical staff for general protection from soiling of spills on the ventral (front) aspect of the body, and typically to prevent penetration of infectious material, during the course of work of a procedure.
Material: Plastic, Polyethylene etc. PVC is not recommended.
Good resistance to tearing and perforation.
Seamless liquid proof and stain resistant.
Straight apron with bib.
Antistatic.
Thickness: not less than: 50 µm.
Can resist water and disinfectant (ethanol 70% and chlorine solution 0.05% of 500 ppm).
Back fastening and neckband should be strong and not detachable.
Colour: Any colour.
Size: One-size-fit-all (120-150 x 70-90 cm)
Single use, disposable.
Non-sterile.
Shelf life 3-5 years
Applicable standards (submissions to be made as per latest revisions):
• EN ISO 13688
• EN 14126-B and partial body protection (EN 13034 of EN 14605)
• EN 343 for water and breathability of equivalent
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of For medical devices used as PPE, both PPE Regulation EU 2016/425 and EU 2017/745 (MDR) apply. For PPE, only the PPE Regulation EU 2016/425 (MDR) applies 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
Packaging and labelling:
- Instruction for use in languages English/ French/Arabic/Spanish of pictograms
Packaging: One (1) unit in a protective packaging.
Manufacturer name and address. mfg. date and expiry
ISO 15223
CE mark (+EC REP), FDA and equivalent.
Lot/batch, manufacturing date and expiry date.
Word ‘non-sterile.’
Word ‘single use' and/of 'disposable.’
These technical specifications are generic and may vary depending on the selected supplier.
Product description:
Apron, disposable, non sterile
This is a disposable, single use garment that must be disposed after one time use.
Intended purpose of use: A garment designed to be worn by medical staff for general protection from soiling of spills on the ventral (front) aspect of the body, and typically to prevent penetration of infectious material, during the course of work of a procedure.
Material: Plastic, Polyethylene etc. PVC is not recommended.
Good resistance to tearing and perforation.
Seamless liquid proof and stain resistant.
Straight apron with bib.
Antistatic.
Thickness: not less than: 50 µm.
Can resist water and disinfectant (ethanol 70% and chlorine solution 0.05% of 500 ppm).
Back fastening and neckband should be strong and not detachable.
Colour: Any colour.
Size: One-size-fit-all (120-150 x 70-90 cm)
Single use, disposable.
Non-sterile.
Shelf life 3-5 years
Applicable standards (submissions to be made as per latest revisions):
• EN ISO 13688
• EN 14126-B and partial body protection (EN 13034 of EN 14605)
• EN 343 for water and breathability of equivalent
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of For medical devices used as PPE, both PPE Regulation EU 2016/425 and EU 2017/745 (MDR) apply. For PPE, only the PPE Regulation EU 2016/425 (MDR) applies 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
Packaging and labelling:
- Instruction for use in languages English/ French/Arabic/Spanish of pictograms
Packaging: One (1) unit in a protective packaging.
Manufacturer name and address. mfg. date and expiry
ISO 15223
CE mark (+EC REP), FDA and equivalent.
Lot/batch, manufacturing date and expiry date.
Word ‘non-sterile.’
Word ‘single use' and/of 'disposable.’
| Pack Size | Avg. Price |
|---|---|
| Pack of 50 | $7.01 |
| Pack of 1 | $11.78 |
| Pack of 100 | $15.20 |
