WARNING LETTER
Pairon Solutions LLC
MARCS-CMS 616392 —
August 09, 2021
Product:
Medical Devices
Recipient:
Pairon Solutions LLC
13970 SW 72nd Ave
Portland
,
OR
97223
United States
melissa@paironsolutions.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
DATE: August 9, 2021
Re: “Arun KN95 Folding Face Mask,” “Deming Surgical Mask,” and “Pairon 3Ply Face Mask” (Blue, White & Black)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.paironsolutionsppe.com/ on July 14, 2021. The FDA has observed that your website offers the “Arun KN95 Folding Face Mask,” the “Deming Surgical Mask”, and the “Pairon 3Ply Face Mask” (Blue, White & Black) 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 website revealed the following statements that establish that the Arun KN95 Folding Face Mask, Deming Surgical Mask, and Pairon 3Ply Face Mask (Blue, White & Black) are intended for the mitigation, prevention, treatment, diagnosis, or cure of disease, including but not limited to:
Statements made alongside an image of the Arun KN95 Folding Face Mask that it is “listed on FDA EUA for Non-NIOSH Devices” and representing compliance with “GB2626-2006” [https://www.paironsolutionsppe.com/products/kn95-mask]
Statements alongside an image of the Deming Surgical Mask that it provides “99% bacterial efficiency” and “complies ASTM F2100”. The name also incorporates the word “surgical” as well as “medical” written on the box packaging [https://www.paironsolutionsppe.com/products/surgical-mask]
Statements made on the packaging and alongside the images of the Pairon 3Ply Face Mask (Blue, White & Black) that they provide “>95% bacterial efficiency” and “helps filter out … bacteria” [https://www.paironsolutionsppe.com/products/general-use-facemask], [https://www.paironsolutionsppe.com/products/copy-of-pairon-3ply-face-mask-black], [https://www.paironsolutionsppe.com/products/white-pairon-3ply-face-mask]
Statements on your firm’s customer blog page representing that the BLUE – Pairon 3Ply Face Mask has been supplied to nursing home facilities [https://www.paironsolutionsppe.com/blogs/news]
Based on our review, your website is offering for sale in the United States, the Arun KN95 Folding Face Mask (which your website represents is manufactured by Dongguan Arun Industrial Co. Ltd.), the Deming Surgical Mask (which your website represents is manufactured by Xiantao Deming Healthcare Products Co., Ltd.), and the Pairon 3Ply Face Mask - Blue, White & Black (which your website represents is manufactured by Wuxi Hingdou Sports Co., Ltd) without marketing approval or clearance 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, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their 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. See 21 CFR 807.39.
Your website contains a number of false or misleading representations, including but not limited to:
Representations that the Arun KN95 Folding Face Masks are “Certified: … FDA” and unauthorized display of what appears to be FDA’s logo
1
on inner packaging of the product [https://www.paironsolutionsppe.com/products/kn95-mask]
Representations that the Deming Surgical Masks are “Certified: FDA” and unauthorized display of what appears to be FDA’s logo on packaging [https://www.paironsolutionsppe.com/products/surgical-mask]
Representations that Pairon 3Ply Face Masks (Blue, White & Black) are “FDA Registered” [https://www.paironsolutionsppe.com/products/general-use-face-mask] [https://www.paironsolutionsppe.com/products/copy-of-pairon-3ply-face-mask-black][https://www.paironsolutionsppe.com/products/white-pairon-3ply-face-mask]
Unauthorized display of what appears to be FDA’s logo alongside the BLACK – Pairon 3Ply Face Mask [https://www.paironsolutionsppe.com/products/copy-of-pairon-3plyface-mask-black]
Displaying a “Certificate of FDA Registration” issued by “UCL-REGSERVICE INC” (UCL-REGSERVICE Certificate) alongside Arun KN95 Folding Face Mask product information. The UCL-REGSERVICE Certificate “certifies that Dongguan Arun Industrial 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 logo
1
and an illustration of an eagle with a U.S. flag (or a similar flag) [https://www.paironsolutionsppe.com/products/kn95-mask]
Displaying a “Certification of Registration” issued by “Sungo Technical Services Inc.” (Sungo Technical Certificate) alongside Deming Surgical Mask product information. The Sungo Technical Certificate “certifies that Xiantao Deming Healthcare Products Co., Ltd., … has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration…” The Sungo Technical Certificate has the look of an official government document, and incorporates unauthorized use of the FDA logo and an illustration of an eagle with a U.S. flag (or a similar flag) [https://www.paironsolutionsppe.com/products/surgical-mask]
Displaying a “Certification of Registration” issued by “Wayborn Quality & Technology Services” (Wayborn Certificate) alongside the BLUE – Pairon 3Ply Face Mask product information. The Wayborn Certificate “certifies that … Wuxi Hingdou Sports Co., Ltd., …has completed U.S. FOOD And DRUG Administration Medical Device Registration…” The Wayborn Certificate has the look of an official government document and incorporates unauthorized use of the FDA logo and an illustration of an eagle with a U.S. flag (or a similar flag). [https://www.paironsolutionsppe.com/products/general-use-face-mask]
To date, FDA has not cleared, approved, authorized or “Certified” the Arun KN95 Folding Face Mask or the Deming Surgical Mask offered for sale by your firm, and so statements to the contrary are false. In addition, display of the FDA logo on packaging and near images of and information about the Arun KN95 Folding Face Mask, the Deming Surgical Mask, and the Pairon 3Ply Face Mask (Blue, White & Black), combined with statements such as, “Certified: FDA” and “FDA Registered”, are misleading because it creates the impression of official FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the devices and/or your establishment.. The UCL-REGSERVICE Certificate bearing the FDA logo, positioned near images of and information about the Arun KN95 Folding Face 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 Dongguan Arun Industrial, Co., Ltd. is or was registered with FDA and that the firm is or was in possession of a registration number. In addition, the display of Sungo Technical Certificate bearing the FDA logo positioned near images of and information about the Deming Surgical Mask is misleading because such display implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishments based on the existence of Xiantao Deming Healthcare Products Co., Ltd. registration and possession of a registration number. Furthermore, display of the Wayborn Certificate bearing the FDA logo, near information about the BLUE – Pairon 3Ply Face Mask is misleading because such display implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the product and/or establishments based on the existence of Wuxi Hingdou Sports Co., Ltd registration and possession of a registration number. Although the Arun KN95 Folding Face Mask, Deming Surgical Mask, and BLUE – Pairon 3Ply Face Mask Certificates contain legible language that appears to be intended to function as a disclaimer, including a statement that the Certificates do 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 such language could be easily overlooked and does 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 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.
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.
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# 616392 or CTS Number CPT2001233 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:
Yabo Zhang
Dongguan Arun Industrial, Co., Ltd.
NO.18Xingfeng St, Changlong, Huangjiang
Dongguan, CN 523766
US Agent:
Simcal
UCL-REG SERVICE INC.
3907 Prince Street Suite 6F
Flushing, NY 11354
Email: gbstandard@163.com
UCL-Reg Service
602 ROCKWOOD ROAD, WILMINGTON
New Castle, DE, 19802
XIANTAO DEMING HEALTHCARE PRODUCTS CO., LTD.
No.198, Pengchang Ave. Pengchang Town, Xiantao City
Hubei Province, P.R. China
Xiantao, CN 433018
Leeyeo Kee
Regrek LLC
19 Holly Cove Ln.
Dover, DE 19901
Email: regrek.cs@hotmail.com
Sungo Technical Services Inc.
6050 W Eastwood Ave Apt. 201 Chicago Illinois 60630
E-mail：sungo.group@yahoo.com
Email: Shage2008@126.com
WUXI HINGDOU SPORTS CO., LTD
Hongdou Industrial Park, Donggang Town
Wuxi, Jiangsu, 214000, China
Director: Crane Yu
Wayborn Quality & Technology Services
306, Xincheng International Main Building,
No.535 Qingshuiqiao Road, Ningbo High-tech Zone
Email: wayborn@wayb.org
___________________________
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:
10/05/2021
Regulated Product(s)
Medical Devices