Medical masks and, Respirators

Medical masks and respirators covered by this policy

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.

Examples of Medical masks

Our policy for Medical masks

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

Required information

We may request this information from you at any time, so we recommend that you have it easily accessible:

• Your company name (if applicable) and seller ID/vendor code
• Your contact information: email address and phone number
• A list of medical masks you wish to list
• Product images for non-sterile face masks you list. Images must include:
  • CE marking (In case of sterile masks, the CE marking should be followed by the 4 Digit notified body number)
  • Name and address of manufacturer (in case the manufacturer is outside the EU, also name and address of the EU authorised representative)
• Declaration of Conformity
• Test report/Certificate from an accredited laboratory confirming each product was tested to applicable requirements listed above (only for non-sterile medical masks)
• EU Type Examination Certificate issued by a notified body (only for sterile medical masks)

Examples of respirators

Our policy for respirators

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

Required information

We may request this information from you at any time, so we recommend that you have it easily accessible:

• Your company name (if applicable) and seller ID/vendor code
• Your contact information: email address and phone number
• A list of respirators you wish to list
• Product images for respirators you list. Images must include:
  • CE marking followed by the 4 Digit notified body number
  • Name and address of manufacturer
• Declaration of Conformity illustrating compliance to: Regulation (EU) 2016/425 on Personal Protective Equipment
• EU Type Examination Certificates (Module B + Module C2 or D) issued by a notified body

Important information regarding child respirators

Respirators designed or advertised for children or kids are prohibited from sale.

How to submit information

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.

Policy violations

If you do not provide the required information by the applicable deadline, we may:

• Remove the relevant product listings
• Suspend your ability to add new products, your listing privileges, or both
• Withhold any payments due to you
• Pursue legal action

We reserve the right to take any further actions that may be necessary in our sole discretion.

Additional resources

Amazon Services Business Solutions Agreement

Remove inventory overview

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