- Medical Devices
Recipient NameDenise Cannon
- Irvin, Inc.
3542 Pineville-Rock Hill Rd (SC Hwy 51)
Fort Mill, SC 29715
- Issuing Office:
- Center for Devices and Radiological Health
DATE: May 27, 2021
RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019
Dear Ms. Cannon:
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at https://theirvincorp.com/covid-19-masks/, on May 7, 2021. The FDA has observed that your website offers the “Irvin KN95 PPE Mask” and “Disposable Face Mask” for sale in the United States. Based on our review, these products are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
FDA’s review of your website revealed the following statements that establish that the Irvin KN95 PPE Mask and Disposable Face Mask are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, including but not limited to:
•Representing the Irvin KN95 PPE Mask and the Disposable Face Mask as “COVID-19 Face Masks” that “protects from viruses…”, “prevents virus”, “a bacterial barrier and sterility, and offers “COVID-19 protection” [https://theirvincorp.com/covid-19-masks/];
•Representing the Disposable Face Mask as “Anti-droplets”[https://theirvincorp.com/covid-19-masks/]
Based on our review, your website is offering for sale in the United States the Irvin KN95 PPE Mask (which your website indicates could be manufactured by Guangzhou Boyan Medical Equipment Technology, Co. Ltd., Tianjin Benmo Medical Equipment Co. Ltd., or Jianxi Yue’an Medical Equipment Co., Ltd.) and the Disposable Face Mask (for which your website does not indicate the manufacturer) without marketing approval, clearance, or authorization from the FDA. Accordingly, these products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). These products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
In addition, the Irvin KN95 PPE Masks are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling is false or misleading. FDA registration of a device establishment or assignment of a registration number does not denote FDA approval of the establishment or the device. Thus, references to a firm’s establishment registration and registration number that create an impression of official FDA approval, clearance, authorization, certification, endorsement or other evaluation of the establishment or the devices are misleading and constitute misbranding. 21 CFR 807.39.
Your website contains a number of false and/or misleading representations, including but not limited to:
• Displayinga “Certificate of FDA Registration” issued by “UCL-REGSERVICE INC” (UCL-REGSERVICE Certificate) alongside Irvin KN95 PPE Mask product information. The UCL-REGSERVICE Certificate “certifies that Tianjin Benmo Medical Equipment CO., LTD… has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” The UCL-REGSERVICE Certificate has the look of an official government document, and incorporates unauthorized use of the FDA logo2 and an illustration of an eagle with a U.S. flag (or a similar flag) [https://theirvincorp.com/wp-content/uploads/2020/04/KN95-Masks-Certification-for-FDA-Registration.pdf].
• Displaying a “Certificate of Conformity” issued by “Shenzhen MONLKA Technology Co., Ltd. (Shenzhen Certificate) alongside Irvin KN95 PPE Mask product information. The Shenzhen Certificate “affirms that [Jianzgxi Yue’an Medical Equipment Co., LTD.] is registered with the U.S. Food and Drug Administration…” The Shenzhen Certificate has the look of an official government document, and incorporates unauthorized use of the FDA logo and an illustration of an eagle [https://theirvincorp.com/wp-content/uploads/2020/04/KN95-Mask-Certificate-of-Conformity.pdf].
• Unauthorized use of the FDA logo displayed alongside images of and information about the Irvin KN95 PPE Mask [https://theirvincorp.com/covid-19-masks/].
The UCL-REGSERVICE Certificate, bearing the FDA logo, positioned near images of and information about the Irvin KN95 PPE Mask is misleading because it implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment based on the representations that Tianjin Benmo Medical Equipment Co., LTD. is or was registered with FDA and that the firm is or was in possession of a registration number. In addition, display of the Shenzhen Certificate, bearing the FDA logo positioned near images of and information about the KN95 PPE Mask is misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product(s) and/or establishment based on the representations that Jianzgxi Yue’an Medical Equipment Co., LTD. is or was registered with FDA and that the firm is or was in possession of a registration number. Although the UCL-REGSERVICE Certificate issued to Tianjin Benmo Medical Equipment Co., LTD. contains language that appears to be intended to function as a disclaimer, including a statement that the Certificate does not denote FDA endorsement or approval, statements that FDA does not issue or recognize certificates of registration, and a statement that quotes 21 CFR 807.39, the small font size and overall placement of the language could be easily overlooked and do not limit or otherwise mitigate the misleading impression created by the use of the Certificate. Further, the unauthorized use of the FDA logo displayed alongside information about and images of the KN95 PPE Mask is misleading because it implies FDA approval, clearance, authorization, endorsement, or other evaluation of the device. These representations are especially concerning from a public health perspective because consumers rely on information provided by sellers to determine whether to purchase a device and your presentation conveys the misimpression that the product has been reviewed and approved by FDA.
We remind you that FDA’s Center for Devices and Radiological Health (CDRH) does not issue device registration certificates to medical device establishments, including to sellers and manufacturers. When an establishment registers and lists its devices, the resulting entry in FDA’s Establishment Registration & Device Listing Database merely denotes that the establishment has provided certain information to FDA.
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.3 In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.4 Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval, clearance, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described above, you sell products that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people. We request that you take immediate action to cease the sale of any adulterated and misbranded products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. This letter is not meant to be an all-inclusive list of violations that exist in connection with the product or your operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. This letter is not meant to be an all-inclusive list of violations that exist in connection with the product or your operations.
It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing the products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, authorized by FDA and that you do not make representations that misbrand the product(s) in violation of the Act.
This letter notifies you of our concerns and provides you with an opportunity to address them. Please notify this office in writing within fifteen 15 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. Your firm’s response should be comprehensive and address all violations included in this letter. If you believe that the product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the Document number CMS Case Number 612738 or CTS Number CPT2000884 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Assistant Director, Paola Barnett at 301-796-5462 or Paola.Barnett@fda.hhs.gov.
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Guangzhou Boyan Medical Equipment Technology, Co. Ltd.
NO 30, Jingu North Rd, Huadong Town, Huadu District
Guangzhou China 51089
9600 Bellaire Blvd
Houston TX 77036
Tianjin Benmo Medical Equipment Co. Ltd
D2-B1,Xuefu Industrial zone west,
No. 2 Xuefu Road, Xiqing District
Tianjin Tianjin, CN 300000
UCL-REG Service Inc.
3907 Prince Street Suite 6F
Flushing, NY US 11354
602 Rockwood Road
New Castle, DE, 19802
Jiangxi Yue’an Medical Equipment Co, Ltd
3rd floor, No.15 Workshop, Wudu Project Area
Industrial Park, Xiushui County
Jiujiang Jiangxi, CN 332400
13611 38th Ave
Flushing, NY US 11354
Shenzhen MONLKA Technology Co., Ltd
Building A, EDerH Industrial District, Fukang Community,
Longhua Subdistrict, Longhua District,
Shenzhen, Guangdong, P. R. China
1 As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2 The FDA logo is for official use by FDA and not for private use on labeling of FDA-regulated products. See FDA Logo Policy (available at: https://www.fda.gov/about-fda/website-policies/fda-logo-policy).
3 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
4 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.