updated CAUTIONS：
FDA Revokes Emergency Use Authorizations for Non-NIOSH-Approved Disposable Respirators and Decontamination Systems as Access to FDA-authorized and NIOSH-approved N95s Increases Nationwide
On June 30, 2021, the FDA announced the revocation of the following EUAs:
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)
As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. For additional information, please see Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities.
Historical information regarding these EUAs can be found on Historical Information about Device Emergency Use Authorizations.
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:
|
| 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 address | Esound Medical Device Co., LTD High-Tech Medical Equipment Industrial Park, Changyuan County, 453400, China |
| Product name | Filtering 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
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