IMPORTANT: These specifications are generic and may vary depending on the selected supplier.
Intended purpose of use: To prevent the user from contamination of mucous membranes of the mouth and nose by infective droplets
Description: Made of clear plastic and providing good visibility to both the wearer and the patient. Adjustable band to attach firmly around the head and fit snugly against the forehead, fog resistant. Completely cover the sides and length of the face.
Technical specifications:
Material, shield part: clear polycarbonate, thickness approx. 0.3 mm
Size shield, down from headband, approx.: 26 x 34 cm (w x h)
Adjustable length headband, integrated with the shield
Width headband, approx.: 3 cm
Front part of the headband is foam padded (length approx. 25 cm)
Shield is anti-fog
Outside is coated to prevent glare from reflection
Shelf life 3-5 years
Instructions for use: When worn together with a properly fitted surgical mask, face shields offer protection from contamination
to others, as well as to the wearer. Where face masks are not available, face shields may be used as an alternative but with limited effectiveness.
Instruction for use in languages English/ French/Arabic/Spanish of pictograms
Cleaning and disinfection procedure (Mass disinfection of multiple face shields of individual shield cleaning as applicable)
Packaging and labelling: One (1) unit in a protective packaging.
Manufacturer name and address.
Lot/batch, MFD and expiry date.
Product reference(s) of item(s) offered
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
Applicable standards ( submissions as per latest revision of standards:)
EN 166 (if reusable)
ANSI/ISEA Z87.1 (if reusable)
of alternative equivalent set of standards
Intended purpose of use: To prevent the user from contamination of mucous membranes of the mouth and nose by infective droplets
Description: Made of clear plastic and providing good visibility to both the wearer and the patient. Adjustable band to attach firmly around the head and fit snugly against the forehead, fog resistant. Completely cover the sides and length of the face.
Technical specifications:
Material, shield part: clear polycarbonate, thickness approx. 0.3 mm
Size shield, down from headband, approx.: 26 x 34 cm (w x h)
Adjustable length headband, integrated with the shield
Width headband, approx.: 3 cm
Front part of the headband is foam padded (length approx. 25 cm)
Shield is anti-fog
Outside is coated to prevent glare from reflection
Shelf life 3-5 years
Instructions for use: When worn together with a properly fitted surgical mask, face shields offer protection from contamination
to others, as well as to the wearer. Where face masks are not available, face shields may be used as an alternative but with limited effectiveness.
Instruction for use in languages English/ French/Arabic/Spanish of pictograms
Cleaning and disinfection procedure (Mass disinfection of multiple face shields of individual shield cleaning as applicable)
Packaging and labelling: One (1) unit in a protective packaging.
Manufacturer name and address.
Lot/batch, MFD and expiry date.
Product reference(s) of item(s) offered
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
Applicable standards ( submissions as per latest revision of standards:)
EN 166 (if reusable)
ANSI/ISEA Z87.1 (if reusable)
of alternative equivalent set of standards
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $2.25 |
| Pack of 10 | $3.67 |
