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This article applies to selling in: Spain

Medical masks, Respirators and Hygienic masks

Important: If you sell products on Amazon, you must comply with all applicable laws and regulations in EU countries and in the UK, as well as Amazon policies applicable to those products and product listings.

Medical masks, Respirators and Hygienic masks 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.

An “hygienic mask” or a “community mask” is a product both reusable (washed or sanitized) and non-reusable (single use), with or without accessories, designed to cover the mouth, nose and chin, equipped with a fastening system normally to the head or ears. Intended use is to minimize the projection of respiratory secretions (including aerosolized particles), which contain saliva, sputum or respiratory secretions when the user speaks, coughs or sneezes, and may also limit the penetration of these secretions of external origin (including aerosolized particles) into the nasal and oral area of the user. These devices are not considered medical nor Personal Protective Equipment.

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 EU, also name and address of the EU authorized 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.


Examples of hygienic masks




Our policy for hygienic masks

Amazon requires that hygienic masks have been tested and meet the specific regulation or standard requirements listed below for all hygienic masks you list:

Product Regulation/Standard requirements
Hygienic mask

UNE 0064-1:2020 or

UNE 0064-2:2020 or

UNE 0065:2020 or

UNE-CWA 17553

At this moment, hygienic masks with valve are not allowed for sale on Amazon.

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 hygienic masks you list.
  • Product images for all hygienic masks you list. Images must include all relevant in Spanish:
    • Name and address of manufacturer (in case the manufacturer is outside EU, also name and address of the European Union authorized representative).
    • Manufacturing batch number (if applicable);
    • Warning;
    • Children warning (if applicable);
    • Common name of the product (“mascarilla higiénica”/ “cobertor facial comunitario”);
    • Number of units in the package (contents of package);
    • Composition of the product;
    • Essential characteristics of the product;
    • Instructions for use on placement;
    • Recommended period of use;
    • Reference to the technical specifications followed.
  • Detail Page contents should match with the information displayed on the product image.
  • Detail Page contents and information displayed on the product image should not content statements related to medical devices.
  • Test report/Certificate from an accredited laboratory confirming each product was tested to applicable requirements listed above.

Some labs provide special Amazon rates for testing. To find more information about these providers, visit the Service Provider Network page.

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, please review all of the information on this page and apply by submitting the required information to eu-life-safety-equipment@amazon.co.uk.

Important: The information provided on this page does not, and is not intended to, constitute legal advice; instead, all information, content and materials are available on this site are for general information purposes only.

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

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