WARNING LETTER
Dongguan City Xinyuan Nonwoven Co., Ltd.
MARCS-CMS 612354 —
May 27, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Alex Wong
Dongguan City Xinyuan Nonwoven Co., Ltd.
No.8, Dajin 2nd Road, Xixi Village, Liaobu Town
Dongguan Shi
Guangdong Sheng
,
523402
China
sales01@xinyuanmask.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
DATE: May 27, 2021
RE: “Disposable Medical Face Mask,” “Wholesale Disposable Medical Protective CE Mask 3 Ply,” and “3 Ply Disposable Medical Filter Nonwoven Face Mask Dust”
Dear Mr. Wong:
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address http://xinyuanmask.com/index.php/culture.html on May 19, 2021. We also reviewed your Alibaba storefront at the Internet address https://dg-xinyuan.en.alibaba.com/?spm=a2700.shop_plser.88.29 on May 12, 2021. The FDA has observed that your firm offers the “Disposable Medical Face Mask,” “Wholesale Disposable Medical Protective CE Mask 3 Ply,” and “3 Ply Disposable Medical Filter Nonwoven Face Mask Dust” for sale in the United States. Based on our review, these products are devices because they 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).
FDA’s review of your websites 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:
•In addition to its name which incorporates the word “medical,” representations that theDisposable Medical Face Mask is a “disposable protective mask” with “filtrationefficiency of > 90%” and “three layers of protection”[http://xinyuanmask.com/index.php/flint/362.html]
•In addition to its name which incorporates the words “medical” and “protective,” representations that the Wholesale Disposable Medical Protective CE Mask 3 Ply is“medical protective clothing ”intended to “isolate 99% of virus [and] protect you fromviruses,” has “3 ply construction to help filter up to 99% bacteria exhaled by the wearer,”and is “designed for general purpose infection control, and helps prevent the spread ofairborne illness” [https://dg-xinyuan.en.alibaba.com/product/1600156122228-822869526/Wholesale_Disposable_Medical_Protective_CE_Mask_3_PLY.html?spm=a2700.shop_plser.41413.19.29a71dd6FQ1kfZ]
• In addition to its name which incorporates the word “medical,” representations that the 3 Ply Disposable Medical Filter Nonwoven Face Mask Dust is a “medical mask” intended to “isolate 99% of virus [and] protect you from viruses,” has “3 ply construction to help filter up to 99% bacteria exhaled by the wearer,” and is “designed for general purpose infection control, and helps prevent the spread of airborne illness” [https://dg-xinyuan.en.alibaba.com/product/1600157940382-822869526/Adult_3Ply_Pack_50_3_Ply_Disposable_Medical_Filter_Nonwoven_Face_Mask_Dust.html?spm=a2700.shop_plser.41413.21.29a71dd6FQ1kfZ]
The Disposable Medical Face Mask, Wholesale Disposable Medical Protective CE Mask 3 Ply, and 3 Ply Disposable Medical Filter Nonwoven Face Mask Dust are being 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). The 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 Disposable Medical 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 device are misleading and constitute misbranding. See 21 CFR 807.39.
Your website, http://xinyuanmask.com/index.php/culture.html, contains a number of false or misleading representations, including but not limited to:
• References to “…CE FDA dual certification…” in the product’s description [http://xinyuanmask.com/index.php/flint/362.html]
• Displaying a “Certificate of FDA Facility Registration and Device Listing of Medical Device” issued by “HUMISS INC.” (HUMISS Certificate) under the “Company qualification” heading, “Product” tab on the product’s webpage. The HUMISS Certificate states that “Dongguan City Xinyuan Nonwoven Co., Ltd.…has completed the Facility Registration and Device Listing with the US FDA...” The HUMISS Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo
1
and an illustration of an eagle. [http://xinyuanmask.com/index.php/integrate.html]
• Displaying a “Certificate of FDA Registration” issued by “Shenzhen STA Testing Co., Ltd.” (Shenzhen Certificate) under the “Company qualification” heading, “Product” tab on the product’s webpage. The Shenzhen Certificate certifies that “Dongguan City Xinyuan Nonwoven Co., Ltd” has “completed the with [sic] FDA Establishment Registration and Device Listing…” The Shenzhen Certificate has the look of an official government document, incorporating unauthorized use of the FDA logo
1
and an illustration of an eagle and a U.S. flag (or a similar flag). [http://xinyuanmask.com/index.php/integrate.html]
The statement referencing FDA “certification” and the display of the HUMISS Certificate and Shenzhen Certificate near images of and information about the Disposable Medical Face Mask are misleading because they imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the device and/or establishment based on representations that Dongguan City Xinyuan Nonwoven Co., Ltd is or was registered with FDA and that the firm is or was in possession of a registration number. Although the HUMISS Certificate and Shenzhen Certificate both contain language that appears to be intended to function as a disclaimer, including statements that the certificates do not denote FDA endorsement or approval and that FDA does not issue or recognize certificates of registration, 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 certificates. Such 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.
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 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 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 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 612354 or CTSDocumentNumber CPT2000770 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.
Sincerely,
/S/
Donna Engleman. MS. BSN.
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Cc:
Humiss Inc.
4845 Pearl East Circle Ste 118
Boulder, CO 80301
Email address: Cc401vip@126.com
Shenzhen STA Testing Co., Ltd.
Room 204, Fuyong Chamber of Commerce Information Building
Road 6348, Baoan District Shenzhen, China
Email address: sta-test@xunda-test.com
________________________
1
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).
Content current as of:
07/06/2021
Regulated Product(s)
Medical Devices