IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: Security glasses to protect against blood and exposure to other human fluids during surgery, midwifery and other medical procedures.
Product description:
Security glasses to protect against blood and exposure to other human fluids during surgery, midwifery and other medical procedures.
Wraparound protective eyewear with wide field view, fits over prescription eyewear
Lightweight and comfortable.
Easy to combine with the wearing of protective masks (surgical/respiratory masks) and over eyeglasses.
Materials: Clear Polycarbonate.
latex free
99.9% UV protection.
Distortion-free
Anti-fog
Abrasion resistant
Adapted to the shape of the face. Integral side-shields and contoured nose bridge.
Flat side arms offering good sideways protection, temple length preferably adjustable.
Weight: approx. 40-60 g
Standard size
Disposable
Instructions for use:
Security glasses to protect against blood and exposure to other human fluids during surgery, midwifery and other medical procedures.
Disposable glasses: to be destroyed if they are soiled of damaged, otherwise they could be reused after cleaning with water and soap.
Never use solvent.
Supplied with:
Manufacturer's instruction for use ( English, French and Spanish)
Packaging and labelling:
Primary packaging: unit of use
One (1) Pair of protective glasses in a sealed plastic bag with instructions for use
Labelling:
- Product name, size, reference number.
- Manufacturer's name and address.
- CE marked of similar
- LOT of batch number
- UDI (if MDR followed)
- use-by-date
- symbol for medical device
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
The words ""for single use"" (of equivalent harmonised symbol).
The words ""destroy after use"" (if space allows) 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
Secondary packaging: Protected unit.
Labelling on the secondary packaging:
Labelling to be the same as primary packaging.
Extra information required:
Number of units per secondary packaging.
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 13485 Medical devices -Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
EN 166 Personal eye-protection - Specification (optic class 1)
EN 167 Personal eye-protection - Optical test methods
EN 170 Personal eye-protection - Ultraviolet filters - Transmittance requirements and recommended use
Environmental requirements:
ISO 14001
These technical specifications are generic and may vary depending on the selected Vendor.
Intended use: Security glasses to protect against blood and exposure to other human fluids during surgery, midwifery and other medical procedures.
Product description:
Security glasses to protect against blood and exposure to other human fluids during surgery, midwifery and other medical procedures.
Wraparound protective eyewear with wide field view, fits over prescription eyewear
Lightweight and comfortable.
Easy to combine with the wearing of protective masks (surgical/respiratory masks) and over eyeglasses.
Materials: Clear Polycarbonate.
latex free
99.9% UV protection.
Distortion-free
Anti-fog
Abrasion resistant
Adapted to the shape of the face. Integral side-shields and contoured nose bridge.
Flat side arms offering good sideways protection, temple length preferably adjustable.
Weight: approx. 40-60 g
Standard size
Disposable
Instructions for use:
Security glasses to protect against blood and exposure to other human fluids during surgery, midwifery and other medical procedures.
Disposable glasses: to be destroyed if they are soiled of damaged, otherwise they could be reused after cleaning with water and soap.
Never use solvent.
Supplied with:
Manufacturer's instruction for use ( English, French and Spanish)
Packaging and labelling:
Primary packaging: unit of use
One (1) Pair of protective glasses in a sealed plastic bag with instructions for use
Labelling:
- Product name, size, reference number.
- Manufacturer's name and address.
- CE marked of similar
- LOT of batch number
- UDI (if MDR followed)
- use-by-date
- symbol for medical device
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
The words ""for single use"" (of equivalent harmonised symbol).
The words ""destroy after use"" (if space allows) 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
Secondary packaging: Protected unit.
Labelling on the secondary packaging:
Labelling to be the same as primary packaging.
Extra information required:
Number of units per secondary packaging.
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 13485 Medical devices -Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
EN 166 Personal eye-protection - Specification (optic class 1)
EN 167 Personal eye-protection - Optical test methods
EN 170 Personal eye-protection - Ultraviolet filters - Transmittance requirements and recommended use
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $2.29 |
