- Medical Devices
- Issuing Office:
- Center for Devices and Radiological Health
DATE: June 4, 2021
Re: “FFP2 NR 5-Layer KN95 Face Mask,” “Medical Face Mask,” and “Sterile Surgical Mask”
Dear Yinlong Dong:
This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at the internet address https://www.xichen-med.com/ on March 23, 2021. The FDA has observed that your website offers the “FFP2 NR 5-Layer KN95 Face Mask,” “Medical Face Mask,” and “Sterile Surgical Mask” for sale in the United States. Based on our review, these products are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, and thus, are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h). We also note that the FFP2 NR 5-Layer KN95 Face Mask is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-191 in people.
FDA’s review of your website revealed the following statements that establish that the products are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, including but not limited to:
• Representing the FFP2 NR 5-Layer KN95 Face Mask as a “COVID-19 Respirator” with “effective antibacterial” properties for use to “prevent…bacteria, droplets and other harmful particles,” “filter germs,” and provide “protection for your family” [https://www.xichen-med.com/mask/ffp2-nr-5-layer-kn95-face-mask.html]
• Representing the Medical Face Mask for use to “prevent infection,” “protect patients and other persons from the transmission of pathogenic microorganisms, body fluids, particulate matter, etc., especially in the event of an epidemic or pandemic,” and provide “protection for your family” as well as offering a “bacterial filtration efficiency [of] > 98%” and “microbial cleanliness [of] <30CFY/g” [https://www.xichen-med.com/mask/disposable-mask.html]
• Representing the Sterile Surgical Mask as a “Medical Surgical Mask” that is “antibacterial” and provides a “BFE above 95%” for use to “prevent the spread of body fluids and body splash content and isolate dust, particle [sic], alcohol, blood, bacteria, and virus invading.” [https://www.xichen-med.com/mask/sterile-surgical-mask.html]
The FFP2 NR 5-Layer KN95 Face Mask, Medical Face Mask, and Sterile Surgical Mask (each of which your website indicates is manufactured by Zhejiang Xichen Medical Technology Co. Ltd) are offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, the 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 FFP2 NR 5-Layer KN95 Face Mask is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its 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 or misleading representations, including but not limited to:
• Displaying a “FDA REGISTRATION CERTIFICATE” also referred to as the “kn95-FDA Certificate” issued by “J & F Technology Services LLC” (Certificate) under the “About Us” tab on your website. The Certificate certifies that “Zhejiang Xichen Medical Technology Co., Ltd…has completed the FDA Establishment Registration (as manufacturer, foreign exporter, contract manufacturer) and Device Listing with the US Food & Drug Administration.” The Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo2 and an illustration of an eagle and a U.S. flag (or a similar flag). [https://www.xichen-med.com/our-certificate]
• Displaying a screenshot titled “kn-95-Registration information is available on the FDA website” of what appears to be Zhejiang Xichen Medical Technology Co., Ltd.’s previous entry in FDA’s Establishment Registration & Device Listing Database. [https://www.xichen-med.com/our-certificate]
Taken together, display of the Certificate, bearing the FDA logo, and a screenshot from FDA’s Establishment Registration & Device Listing Database positioned near images of and information about the FFP2 NR 5-Layer KN95 Face Mask are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishment based on the representations that Zhejiang Xichen Medical Technology Co., Ltd. is or was registered with the FDA and that the firm is or was in possession of a registration number. Although the Certificate appears to be intended to function as a disclaimer, the small font size and overall placement of such language could be easily overlooked and does not limit or otherwise mitigate the misleading impression created by the use of the Certificate. We also note that you seem to reference the Certificate or some other certificate on the Sterile Surgical Mask’s webpage [https://www.xichen-med.com/mask/sterilesurgical-mask.html], indicating the product has a “Certificate CE, FDA.” 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 products have 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 a product 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 products 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 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 address 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 any actions your firm has taken. If your firm’s planned 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 products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
If you are not located in the United States, please note that products that appear to be adulterated or misbranded may be detained or refused admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your products listed above to be adulterated and misbranded products that cannot be legally sold to consumers in the United States.
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# 612946 or CTS Number CPT2001023 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.
Donna Engleman, MS, BSN
Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
US Agent: Fanny Zhao
J & F Technology Services LLC
2424 Morris Ave 818
Union, New Jersey 07083
Email Address: email@example.com
XICEN International Gmb
Global Office Center, Beethovenstr. 5
Email Address: firstname.lastname@example.org
XICEN International Corporation
245 E. Main Street, Suite 107
Alhambra, California, 91801
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/proclamationdeclaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.