A “medical mask” is a face mask originally intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.
A “respirator” is a particle filtering half mask which covers the nose, mouth and chin and may have inhalation and/or exhalation valve(s). The half mask consists entirely or substantially of filter material or comprises a face piece in which the main filter(s) form an inseparable part of the device. It is intended to provide adequate sealing on the face of the wearer against the ambient atmosphere, when the skin is dry or moist and when the head is moved. Air enters the particle filtering half mask and passes directly to the nose and mouth area of the face piece or, via an inhalation valve(s) if fitted. The exhaled air flows through the filter material and/or an exhalation valve (if fitted) directly to the ambient atmosphere. These devices are designed to protect against both solid and liquid aerosols.
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Amazon requires Medical masks to be tested and meet the regulation(s) and standard requirements listed below:
Product | Regulation/Standard requirements |
Medical masks |
Regulation 2017/745 or 93/42/EEC on Medical devices + EN 14683 |
We may request this information from you at any time, so we recommend that you have it easily accessible:
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Amazon requires the respirators to be certified in line with requirements of specific regulation(s) and standards listed below:
Product | Regulation/Standard requirements |
Respirator |
Regulation (EU) 2016/425 on Personal Protective Equipment + EN 149 |
We may request this information from you at any time, so we recommend that you have it easily accessible:
Respirators designed or advertised for children or kids are prohibited from sale.
Amazon’s policies require that certain life safety products sold through Amazon meet certification standards. To sell these products on Amazon, review all of the information on this page and apply by submitting the required information to eu-life-safety-equipment@amazon.co.uk.
If you do not provide the required information by the applicable deadline, we may:
We reserve the right to take any further actions that may be necessary in our sole discretion.