Captain's Cloth LLC

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://captainscloth.com/ on June 10, 2021, where you offer the “KN95 Face Mask” for sale in the United States. We also reviewed your social media page at https://www.facebook.com/Captains-Cloth-140013110203384/ where you direct consumers to your website to purchase the KN95 Face Mask. 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 KN95 face masks 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:

Statements alongside an image of the KN95 Face Masks that they “filter out 95% of particles” and that your firm is “working primarily with medical distribution companies … to support those on the front lines” [https://captainscloth.com/products/kn95-face-masks-5-pack]

Statements made on the KN95 Face Mask packaging that “This product can filter air particulates, dust, smoke, mist, microorganisms, block droplets, body fluids, secretions…” and “Prevent Virus” [https://captainscloth.com/products/kn95-face-masks-5-pack]

The KN95 Face Mask, which your website represents is manufactured by “Lianyungang Manai Protective Equipment Co. Ltd.” (Lianyungang) is offered for sale in the United States without marketing approval, clearance, or authorization from the FDA. Accordingly, this product is 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). This product is 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 KN95 Face Mask is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because its labeling is false or misleading. Specifically, your websites contain false or misleading representations, including but not limited to:

Representations that the KN95 Face Masks “have an active status with the FDA…” [https://captainscloth.com/products/kn95-face-masks-5-pack]

Unauthorized display of what appears to be FDA’s logo1 on the front and back of the product’s labeling [https://captainscloth.com/products/kn95-face-masks-5-pack]

Display of the FDA logo on packaging and near images of and information about the respective products, combined with statements about having active status with the FDA, is misleading because such information implies FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the products and/or establishments. 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.

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.

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# 611829 or CTS Number CPT2001007 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.