[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-captains-cloth-llc-613965-07022021":3,"fda-latest-sync-dates":30},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":13,"case_status":14,"letter_url":15,"reference_number":8,"marcs_cms_no":16,"product_type":17,"delivery_method":8,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":28,"updated_at":29},3214,"captains-cloth-llc-613965-07022021","Warning Letter","Captain's Cloth LLC",null,"Center for Devices and Radiological Health","Investigational Device Exemptions (IDE)\u002FPremarket Approval Application (PMA)","2021-08-10","2021-07-02","2021-10-07","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fcaptains-cloth-llc-613965-07022021","613965","Medical Devices","Brian Eckert","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Medical Devices                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Brian Eckert\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Captain's Cloth LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">28871 El Apajo\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Laguna Niguel\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">92677\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:Brian@eckertsales.com\"> Brian@eckertsales.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:info@captainscloth.com\"> info@captainscloth.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Devices and Radiological Health\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>DATE: July 2, 2021\u003C\u002Fp>\n\n\u003Cp>Re: “KN95 Face Mask”\u003C\u002Fp>\n\n\u003Cp>Dear Brian Eckert:\u003C\u002Fp>\n\n\u003Cp>This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fcaptainscloth.com\u002F 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:\u002F\u002Fwww.facebook.com\u002FCaptains-Cloth-140013110203384\u002F 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).\u003C\u002Fp>\n\n\u003Cp>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:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>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:\u002F\u002Fcaptainscloth.com\u002Fproducts\u002Fkn95-face-masks-5-pack]\u003C\u002Fli>\n\t\u003Cli>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:\u002F\u002Fcaptainscloth.com\u002Fproducts\u002Fkn95-face-masks-5-pack]\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>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).\u003C\u002Fp>\n\n\u003Cp>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:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>Representations that the KN95 Face Masks “have an active status with the FDA…” [https:\u002F\u002Fcaptainscloth.com\u002Fproducts\u002Fkn95-face-masks-5-pack]\u003C\u002Fli>\n\t\u003Cli>Unauthorized display of what appears to be FDA’s logo\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> on the front and back of the product’s labeling [https:\u002F\u002Fcaptainscloth.com\u002Fproducts\u002Fkn95-face-masks-5-pack]\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>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\u002For 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.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>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 letter. If you believe that the products are not in violation of the Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\n\n\u003Cp>Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to:\u003C\u002Fp>\n\n\u003Cp>Food and Drug Administration\u003Cbr>\nCenter for Devices and Radiological Health\u003Cbr>\nOffice of Regulatory Programs\u003Cbr>\nDivision of Regulatory Programs 2: Establishment Support\u003Cbr>\nRegulatory Inspections and Audits Team\u003Cbr>\nWhite Oak Building 66\u003Cbr>\n10903 New Hampshire Ave.\u003Cbr>\nSilver Spring, MD 20993\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Donna Engleman, MS, BSN\u003Cbr>\nDirector\u003Cbr>\nDivision of Market Intelligence\u003Cbr>\nOffice of Regulatory Programs\u003Cbr>\nOffice of Product Evaluation and Quality\u003Cbr>\nCenter for Devices and Radiological Health\u003Cbr>\n \u003C\u002Fp>\n\n\u003Cp>Cc:\u003Cbr>\nYoubiao Wei\u003Cbr>\nLianyungang Manai Protective Equipment Co., Ltd.\u003Cbr>\nJinshan Town Industrial Park, Ganyu District\u003Cbr>\nLianyangang, Jiangsu CN 222002\u003C\u002Fp>\n\n\u003Cp>US Agent:\u003Cbr>\nHong\u003Cbr>\n38 South 18th Avenue, Suite A Brighton, CO 80601\u003Cbr>\nEmail: abmedservice@outlook.com\u003C\u002Fp>\n\n\u003Cp>Lianyungang Manai Protective Equipment Co., Ltd.\u003Cbr>\nNo. 6 Building, 1-8 North Street, Sanyuanli Yaochi, Yuexiu District\u003Cbr>\nGuangzhou, Guangdong CN 510030\u003C\u002Fp>\n\n\u003Cp>Official Correspondent:\u003Cbr>\nShuo Wang\u003Cbr>\nLianyungang Manai Protective Equipment Co., Ltd.\u003Cbr>\nKuangquan Street Yaochi North Street Community\u003Cbr>\nGuangzhou, Guangdong CN 510030\u003C\u002Fp>\n\n\u003Cp>___________________________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> 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: \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fabout-fda\u002Fwebsite-policies\u002Ffda-logo-policy\">https:\u002F\u002Fwww.fda.gov\u002Fabout-fda\u002Fwebsite-policies\u002Ffda-logo-policy\u003C\u002Fa>).\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Product:\n\nMedical Devices\n\nRecipient:\n\nRecipient Name\n\nBrian Eckert\n\nCaptain's Cloth LLC\n\n28871 El Apajo\n\nLaguna Niguel, CA 92677\n\nUnited States\n\nBrian@eckertsales.com\n\ninfo@captainscloth.com\n\nIssuing Office:\n\nCenter for Devices and Radiological Health\n\nUnited States\n\nWARNING LETTER\n\nDATE: July 2, 2021\n\nRe: “KN95 Face Mask”\n\nDear Brian Eckert:\n\nThis is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fcaptainscloth.com\u002F 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:\u002F\u002Fwww.facebook.com\u002FCaptains-Cloth-140013110203384\u002F 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).\n\nFDA’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:\n\nStatements 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:\u002F\u002Fcaptainscloth.com\u002Fproducts\u002Fkn95-face-masks-5-pack]\n\nStatements 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:\u002F\u002Fcaptainscloth.com\u002Fproducts\u002Fkn95-face-masks-5-pack]\n\nThe 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).\n\nIn 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:\n\nRepresentations that the KN95 Face Masks “have an active status with the FDA…” [https:\u002F\u002Fcaptainscloth.com\u002Fproducts\u002Fkn95-face-masks-5-pack]\n\nUnauthorized display of what appears to be FDA’s logo1 on the front and back of the product’s labeling [https:\u002F\u002Fcaptainscloth.com\u002Fproducts\u002Fkn95-face-masks-5-pack]\n\nDisplay 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\u002For 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.\n\nThis 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.\n\nThis 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 letter. If you believe that the products are not in violation of the Act, include your reasoning and any supporting information for our consideration.\n\nYour firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to:\n\nFood and Drug Administration\n\nCenter for Devices and Radiological Health\n\nOffice of Regulatory Programs\n\nDivision of Regulatory Programs 2: Establishment Support\n\nRegulatory Inspections and Audits Team\n\nWhite Oak Building 66\n\n10903 New Hampshire Ave.\n\nSilver Spring, MD 20993\n\nRefer 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.\n\nSincerely,\n\n\u002FS\u002F\n\nDonna Engleman, MS, BSN\n\nDirector\n\nDivision of Market Intelligence\n\nOffice of Regulatory Programs\n\nOffice of Product Evaluation and Quality\n\nCenter for Devices and Radiological Health\n\nCc:\n\nYoubiao Wei\n\nLianyungang Manai Protective Equipment Co., Ltd.\n\nJinshan Town Industrial Park, Ganyu District\n\nLianyangang, Jiangsu CN 222002\n\nUS Agent:\n\nHong\n\n38 South 18th Avenue, Suite A Brighton, CO 80601\n\nEmail: abmedservice@outlook.com\n\nLianyungang Manai Protective Equipment Co., Ltd.\n\nNo. 6 Building, 1-8 North Street, Sanyuanli Yaochi, Yuexiu District\n\nGuangzhou, Guangdong CN 510030\n\nOfficial Correspondent:\n\nShuo Wang\n\nLianyungang Manai Protective Equipment Co., Ltd.\n\nKuangquan Street Yaochi North Street Community\n\nGuangzhou, Guangdong CN 510030\n\n___________________________________\n\n1 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:\u002F\u002Fwww.fda.gov\u002Fabout-fda\u002Fwebsite-policies\u002Ffda-logo-policy).","2026-08-20T02:42:40.363+00:00",[23,24,25,9,10,26,27,26],"\u003Ctime datetime=\"2021-08-10T13:20:00Z\">08\u002F10\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-07-02T04:00:00Z\">07\u002F02\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fcaptains-cloth-llc-613965-07022021\">Captain's Cloth LLC\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fcaptains-cloth-613965-09272021\">\u003Ctime datetime=\"2021-10-07T04:00:00Z\">10\u002F07\u002F2021\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:29.386127+00:00","2026-08-20T02:42:42.482382+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]