{"id":4207,"date":"2020-05-14T10:00:09","date_gmt":"2020-05-14T09:00:09","guid":{"rendered":"https:\/\/one-pointzero.com\/?p=4207"},"modified":"2020-06-12T15:39:51","modified_gmt":"2020-06-12T14:39:51","slug":"us-remove-74-of-all-chinese-n95-mask-manufacturers-from-the-fda-approved-list","status":"publish","type":"post","link":"https:\/\/one-pointzero.com\/technology\/us-remove-74-of-all-chinese-n95-mask-manufacturers-from-the-fda-approved-list\/","title":{"rendered":"US Remove 74% of all Chinese N95 Mask Manufacturers from the FDA Approved List"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_column_text]<\/p>\n<h4><span data-contrast=\"auto\">On Friday<\/span><span data-contrast=\"auto\">\u00a08<\/span><span data-contrast=\"auto\">th<\/span><span data-contrast=\"auto\">\u00a0May<\/span><span data-contrast=\"auto\">,\u00a0<\/span><span data-contrast=\"auto\">the US Food and Drug Administration<\/span><span data-contrast=\"auto\">\u00a0(FDA)<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">cut the\u00a0<\/span><span data-contrast=\"auto\">approved list<\/span><span data-contrast=\"auto\">\u00a0of Chinese vendors<\/span><span data-contrast=\"auto\">\u00a0who make N95 masks<\/span><span data-contrast=\"auto\">\u00a0to just 14<\/span><span data-contrast=\"auto\">, down for 86<\/span><span data-contrast=\"auto\">. The\u00a0<\/span><span data-contrast=\"auto\">official\u00a0<\/span><span data-contrast=\"auto\">reason for\u00a0<\/span><span data-contrast=\"auto\">this\u00a0<\/span><span data-contrast=\"auto\">is product failing to pass the required testing<\/span><span data-contrast=\"auto\">\u00a0that each mask must adhere to<\/span><span data-contrast=\"auto\">.\u00a0<\/span><span data-contrast=\"auto\">This means that there are now only 14 Chinese vendors who can legally ship N95 masks to the US.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h4>\n<h4><span data-contrast=\"auto\">Spot checks across the remaining approved supplier shipments are in place to ensure that the standard does not fall below the accepted level. Any supplier that has had their approval revoked can apply to have their products retested by the\u00a0<\/span><span data-contrast=\"auto\">National Institute for Occupational Safety and Health<\/span><span data-contrast=\"auto\">\u00a0(NIOSH) within 45 days. If they pass, they may be allowed back on the list and free to sell within the US.\u00a0<\/span><span data-contrast=\"auto\">For more information on the FDA\u2019s standards and testing requirements, please see\u00a0<\/span><a href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=c9c15fd462ffe5c4f4e85b73f161b2e0&amp;r=PART&amp;n=42y1.0.1.7.67\" target=\"_blank\" rel=\"noopener noreferrer\"><span data-contrast=\"none\"><span style=\"color: #3366ff;\">here<\/span><\/span><\/a>.<\/h4>\n<h4><span data-contrast=\"auto\">It is critical that\u00a0<\/span><span data-contrast=\"auto\">all recommended<\/span><span data-contrast=\"auto\">\u00a0masks<\/span><span data-contrast=\"auto\">, including N95,<\/span><span data-contrast=\"auto\">\u00a0meet the\u00a0<\/span><span data-contrast=\"auto\">stringent<\/span><span data-contrast=\"auto\">\u00a0medical standards<\/span><span data-contrast=\"auto\">\u00a0laid out by the FDA,<\/span><span data-contrast=\"auto\">\u00a0otherwise wearers\u00a0<\/span><span data-contrast=\"auto\">could be<\/span><span data-contrast=\"auto\">\u00a0put at significant risk<\/span><span data-contrast=\"auto\">. For detailed information on the advised face masks for prevention against COVID19, please read our article\u00a0<\/span><span style=\"color: #3366ff;\"><a style=\"color: #3366ff;\" href=\"https:\/\/one-pointzero.com\/one-point-zeros-covid19-mask-information-for-buyers\/\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a><\/span><span data-contrast=\"auto\">.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h4>\n<h4><span data-contrast=\"auto\">\u00a0It is understandable that the US is protecting its citizens from unregulated masks, however, with their infection rate not yet slowing, there is an urgent need for more protective equipment\u00a0<\/span><span data-contrast=\"auto\">by<\/span><span data-contrast=\"auto\">\u00a0their frontline workers. Unfortunately, this move will likely cause an increase in pricing and expand lead times as these masks are now a\u00a0<\/span><span data-contrast=\"auto\">far\u00a0<\/span><span data-contrast=\"auto\">rarer commodity.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h4>\n<p>&nbsp;<\/p>\n<h4><span data-contrast=\"auto\">We at One Point Zero take safety very seriously and we do not provide our clients<\/span><span data-contrast=\"auto\">\u00a0with<\/span><span data-contrast=\"auto\">\u00a0anything b<\/span><span data-contrast=\"auto\">ut<\/span><span data-contrast=\"auto\">\u00a0the best. Our product<\/span><span data-contrast=\"auto\">s<\/span><span data-contrast=\"auto\">\u00a0consistently ran<\/span><span data-contrast=\"auto\">k<\/span><span data-contrast=\"auto\">\u00a0top in\u00a0<\/span><span data-contrast=\"auto\">comparative<\/span><span data-contrast=\"auto\">\u00a0testing with other suppliers, often surpassing<\/span><span data-contrast=\"auto\">\u00a0the testing requirements by a significant margin.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h4>\n<h4><span data-contrast=\"auto\">We\u00a0<\/span><span data-contrast=\"auto\">want to assure all our c<\/span><span data-contrast=\"auto\">lient<\/span><span data-contrast=\"auto\">s that we are working tirelessly to ensure continuity of supply<\/span><span data-contrast=\"auto\">. O<\/span><span data-contrast=\"auto\">ur\u00a0<\/span><span data-contrast=\"auto\">diligent\u00a0<\/span><span data-contrast=\"auto\">team\u00a0<\/span><span data-contrast=\"auto\">is in direct communication with all the relevant government bodies\u00a0<\/span><span data-contrast=\"auto\">to ensure that this new move by\u00a0<\/span><span data-contrast=\"auto\">the FDA has minimum impact to our clients and their orders.\u00a0<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/h4>\n<p>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_column_text] On Friday\u00a08th\u00a0May,\u00a0the US Food and Drug Administration\u00a0(FDA)\u00a0cut the\u00a0approved list\u00a0of Chinese vendors\u00a0who make N95 masks\u00a0to just 14, down for 86. The\u00a0official\u00a0reason for\u00a0this\u00a0is product failing to pass the required testing\u00a0that each mask must adhere to.\u00a0This means that there are now only 14 Chinese vendors who can legally ship N95 masks to the US.\u00a0\u00a0 Spot checks across<\/p>\n","protected":false},"author":2,"featured_media":4209,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[47],"tags":[126,125,190,127,193,192,128,191],"class_list":["post-4207","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-coronavirus","tag-covid19","tag-fda","tag-masks","tag-n95","tag-regulations","tag-supply-chain","tag-us"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>US Remove 72 of N95 Mask Manufacturers from the FDA Approved List<\/title>\n<meta name=\"description\" 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