ESound Med

ESound Med EN149 FFP2 protective masks, medical disposable protective mask facemask N95 equivalent with FDA EUA

  • individually wrapped, sterile, 4 ply, with earloops or headstraps.
  • Meet the standard of Chinese Medical Protective mask GB 19083-2010 and protective mask GB2626-2019.
  • on the FDA Emergency Use Authorization List, EUA FDA Approved 20182140615 Folded mask.
  • with CDC Confirmed Filtration Efficiency (You can find them at the end of this page).
Category: Tag:

User Information

 

Manufacturers Name: ESound Medical Device Co., LTD

Manufacturers Address: High-Tech Medical Equipment Industrial Park, Changyuan County, 453400, China

Product Name: Filtering half mask

Product Model: mpm02

The risk against which the PPE is designed to protect:

This filtering half mask is suitable for respiratory protection against particles.

This protective mask is manufactured for the COVID-19 protection only. This protective mask is not a PPE device for general use and shall not be used for purposes other than protection against COVID-19.

User Instruction:

  • Step 1: Cup the mask in your hand with the nose clip at your fingertips;
  • Step 2: Cover your chin, mouth and nose with the nose clip up;
  • Step 3: Pull the two straps to your ears, resting them at your ears. Be sure to put on the buckle;
  • Step 4: Mould the nose clip to the shape of your nose, from the middle to the side, using your fingertips of each hand at the same time.
Cautions:

1. Check whether the package is intact before use. Confirm the label, production date and period of validity. Use within the period of validity.

2. Do not use if the package is damaged.

3. The product should be used as soon as possible after the package is opened.

4. When the fitness between the face and the mask is affected by mustache, facial hair or other factors, do not use the mask.

5. The product shall NOT be used for more than one shift.

References to Regulation & Technical Specification:

Regulation: The European PPE Regulation (EU) 2016/425;

Technical specification: BSI’s PPE for Healthcare Professionals 2020/403 – Respiratory Protective Equipment

Module B Notified Body details:

BSI Group, The Netherlands B.V., Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands, Notified Body No. 2797

Storage conditions:

Store in a dry and clean warehouse with excellent ventilation and no corrosive gas where the relative humidity is less than 80%.

Production serial number & date and date of expiry:

On the package.

EU Declaration of Conformity:

EU Declaration of Conformity can be found on this site.

 

EU Declaration of Conformity

 

This declaration of conformity is issued under the sole responsibility of the manufacturer:

 

Manufacturer and addressEsound Medical Device Co., LTD

High-Tech Medical Equipment Industrial Park, Changyuan County, 453400,

China

Product nameFiltering half mask
Model/ Serial No.mpm02
Technical Reference:BSI’s PPE Technical Specification for Healthcare Professionals during the Covid-19 Pandemic
Applicable Regulation:PPE Regulation 2016/425
Notified body for EU type-examination

(Module B)

BSI Group – NB 2797
The Netherlands BV, Say Building, John M Keynesplein 9,
1066 EP, Amsterdam, Netherlands
Notified body for EU conformity to type plus supervised product checks (Module C2) BSI Group – NB 2797
The Netherlands BV, Say Building, John M Keynesplein 9,
1066 EP, Amsterdam, Netherlands
Certificate number CE 730582, CE 730578

 

We declare that given information on the above statement and attached documents / records are true and correct to the best of our knowledge.

Signed for and on behalf of ESound Medical Device Co., LTD:

Changyuan, Henan, China

30-06-2020

 

 

Provide Equivalent Protection as N95

Non-NIOSH approved N95 but with FDA EUA , 7th-June-2020
https://www.fda.gov/media/136663/download

CDC Test Report:

https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html

color

White

Enquiry

Reviews

  1. Carlos Augusto Hernandez Garcia

    The masks arrived in perfect conditions.

  2. Jeffrey Goins

    I like this mask.
    Is it available for purchase in the USA?

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