"Intended use: Security glasses to protect (shield) against blood and exposure to other human fluids during surgery, midwifery, or while performing a clinical, laboratory, or other medical procedure. Reusable device.
Product description:
Wraparound protective eyewear with wide field view, fits over prescription eyewear
Easy to combine with the wearing of protective masks (surgical/respiratory masks) and over eyeglasses.
Materials: High-impact polycarbonate lenses, latex-free, highly resistant to disinfectants and clinical cleaning solutions
Anti-fog and anti-scratch coatings
Absorption of 99.9% UV rays
Distortion-free
Abrasion resistant
Adapted to the shape of the face. Integral side shields and a contoured nose bridge. Lightweight
Flat side arms offering good sideways protection, ensuring minimal exposure gaps, and temple length preferably adjustable.
Regular size
Reusable-type for long-term use
Supplied with:
Manufacturer's instruction for use in English
Packaging and labeling:
Primary packaging: unit of use
One (1) Pair of protective glasses in a sealed plastic bag with instructions for use
Labeling:
- Product name, size, and reference number.
- CE marked or similar
Secondary packaging: Protected unit.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note: For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year. OR US FDA 510(K) clearance
Classification:
Classified under EU MDR 2017/745 as Class I device (Declaration of Conformity by the Manufacturer)
Safety & product Standards:
Must comply with following standards
ISO 13485 Medical devices -Quality management systems -- Requirements for regulatory purposes
ANSI Z87.1-2010 Safety standard developed by the American National Standards Institute (ANSI) in partnership with ISEA (International Safety Equipment Association) for eye and face protection against impact, non-ionizing radiation (IV, infrared), chemical exposure, dust or fine particles, splash or droplets.
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
"
Product description:
Wraparound protective eyewear with wide field view, fits over prescription eyewear
Easy to combine with the wearing of protective masks (surgical/respiratory masks) and over eyeglasses.
Materials: High-impact polycarbonate lenses, latex-free, highly resistant to disinfectants and clinical cleaning solutions
Anti-fog and anti-scratch coatings
Absorption of 99.9% UV rays
Distortion-free
Abrasion resistant
Adapted to the shape of the face. Integral side shields and a contoured nose bridge. Lightweight
Flat side arms offering good sideways protection, ensuring minimal exposure gaps, and temple length preferably adjustable.
Regular size
Reusable-type for long-term use
Supplied with:
Manufacturer's instruction for use in English
Packaging and labeling:
Primary packaging: unit of use
One (1) Pair of protective glasses in a sealed plastic bag with instructions for use
Labeling:
- Product name, size, and reference number.
- CE marked or similar
Secondary packaging: Protected unit.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note: For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year. OR US FDA 510(K) clearance
Classification:
Classified under EU MDR 2017/745 as Class I device (Declaration of Conformity by the Manufacturer)
Safety & product Standards:
Must comply with following standards
ISO 13485 Medical devices -Quality management systems -- Requirements for regulatory purposes
ANSI Z87.1-2010 Safety standard developed by the American National Standards Institute (ANSI) in partnership with ISEA (International Safety Equipment Association) for eye and face protection against impact, non-ionizing radiation (IV, infrared), chemical exposure, dust or fine particles, splash or droplets.
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
"
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.65 |
| Pack of 10 | $7.36 |
