FDA Emergency Use Authorization for Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Face piece Respirators

These references are provided to our customers to make informed decisions about the purchase and use of KN95 Masks sold by Ritter Implants and manufactured by Shenzhen Horb Technology Corp., Ltd.

 

Date: March 28, 2020

Title: Letter: Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators; Health Care Personnel; Hospital Purchasing Departments and Distributors; Importers and Commercial Wholesalers; and Any Other Applicable Stakeholders.

Description: First Letter Issued

Link to Document

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Date: April 3, 2020

Title: Revised Letter: Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators; Health Care Personnel; Hospital Purchasing Departments and Distributors; Importers and Commercial Wholesalers; and Any Other Applicable Stakeholders

Descriptions: Regulations changed on submission requirements and approval for being added to Appendix A. Shenzhen Horb Technology Corp., Ltd met the requirements and submitted documentation to FDA to be added to Appendix A.

Link to Document

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Date: April 15, 2020

Title: Letter: Shenzhen Horb EUA Certificate

Description: Shenzhen Horb Technology Corp., Ltd was notified by FDA that they were added to the Appendix A: Authorized Respirators List.

Link to Document

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Date: April 24, 2020

Title: Appendix A: Authorized Respirators List.

Description: Shenzhen Horb Technology Corp., Ltd was added to list.

Link to Document

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Date: April 30, 2020

Title: Received Shipment of Product

Description: Ritter Implants received the first shipment of KN95 Kanbo Mask from Shenzhen Horb Technology Corp., Ltd

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Date: May 5, 2020

Title: Received Shipment of Product

Description: Ritter Implants received the second shipment of KN95 Kanbo Mask from Shenzhen Horb Technology Corp., Ltd

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Date: May 7, 2020

Title: Revised Letter: Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators; Health Care Personnel; Hospital Purchasing Departments and Distributors; Importers and Commercial Wholesalers; and Any Other Applicable Stakeholders.

Description:

Removal from Appendix A Explanation in Letter:

On May 7, 2020, in response to questions and concerns that have been received by FDA since issuance of the April 3, 2020 letter and having concluded that revising the April 3, 2020 EUA is appropriate to protect the public health or safety under section 564(g)(2)(C) of the Act (21

U.S.C. § 360bbb-3(g)(2)(C)), FDA is reissuing the April 3, 2020 letter with certain revisions.3

Specifically, FDA has revised the April 3, 2020 EUA for clarity and to address concerns about sub-standard products, which includes revising the third criterion for eligibility and adding a process for removal from Appendix A.

To be added back to Appendix A Explanation in Letter:

“It was previously listed in Appendix A under the April 3, 2020 letter of authorization as an authorized respirator because it demonstrated acceptable performance to applicable standards as documented by test reports, has had particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEB- APR-STP-0059 within 45 calendar days of the date of issuance of this EUA, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent.”

Link to Document 

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Date: May 7, 2020

Title: Appendix A: Authorized Respirators List.

Description: Shenzhen Horb Technology Corp., Ltd was no longer listed & All manufacturers that were added after April 3, 2020 Letter were removed from list.

Link to Document Appendix A

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Date: May 15, 2020

Title: Respirator Models Removed from Appendix A (Updated: May 11, 2020)

Description: Shenzhen Horb Technology Corp., Ltd was listed on the removed list

Link to Document