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天華超淨(300390.SZ)子公司獲《江蘇省緊急醫用物資防護服、口罩應急生產使用備案件》
格隆匯 02-14 19:30

格隆匯2月14日丨天華超淨(300390.SZ)公佈,公司2020年2月14日收到全資子公司無錫市宇壽醫療器械有限公司(“宇壽醫療”)的通知,宇壽醫療獲得江蘇省藥品監督管理局出具的《江蘇省緊急醫用物資防護服、口罩應急生產使用備案件》(備案號:蘇臨20200007號和蘇臨20200008號)。

1、緊急物資醫用防護服備案件(備案號:蘇臨20200008號),產品名稱:緊急物資醫用防護服;型號規格:型號為連身式、分身式,規格為160、165、170、175、180、185;結構及組成:本產品由連帽上衣、褲子組成,袖口、腳踝口、帽子面部收口及腰部收口採用彈性收口。主要材料為滌綸高密機織物,結構分為連身式和分身式兩種,產品經環氧乙烷滅菌。適用範圍:適用於接觸具有潛在感染性的患者血液、體液、分泌物、空氣中的顆粒物等提供阻隔、防護作用。產品有效期:2年;備案結論:僅用於國內疫情防控應急使用。標籤、標識應在明顯處標註“僅供應急使用,產品經環氧乙烷滅菌”。有效期至:2020年4月13日;備案件備註:企業在備案期間生產的產品僅供各級疫情聯防聯控機制物資保障組統一調配使用。企業應每週向所屬地檢查分局報送產能和銷售去向。

2、緊急物資醫用外科口罩備案件(備案號:蘇臨20200007號),產品名稱:緊急物資醫用外科口罩;型號規格:14.5cm×9.5cm、15.0cm×7.5cm、17.5cm×8.5cm、17.5cm×9.5cm、17.5cm×10.0cm。結構及組成:本產品由口罩體、鼻夾(聚乙烯或金屬條)、口罩帶(滌綸低彈絲-氨綸絲)三部分組成。其中口罩體第一層為白色或彩色紡粘無紡布(聚丙烯),第二層為聚丙烯熔噴布,第三層為白色紡粘無紡布(聚丙烯),產品經環氧乙烷滅菌。適用範圍:供臨牀醫務人員在有創操作過程中佩戴,覆蓋住使用者的口、鼻及下頷,為防止病原體微生物、體液、顆粒物等的直接透過物理屏障。產品有效期:2年;備案結論:僅用於國內疫情防控應急使用。標籤、標識應在明顯處標註“僅供應急使用”。有效期至:2020年4月13日;備案件備註:企業在備案期間生產的產品僅供各級疫情聯防聯控機制物資保障組統一調配使用。企業應每週向所屬地檢查分局報送產能和銷售去向。

此次備案件申請的緊急物資醫用防護服,是天華超淨為應戰疫情而緊急啟動的醫用防護服項目,聯合全資子公司宇壽醫療共同開發,產品將全部採用天華超淨研發的以滌綸機織物為基材的特種醫用防護面料,充分發揮公司在防靜電無塵人體防護產品方面已有的技術優勢,積極響應國家應對新型冠狀病毒肺炎疫情防治所需應急醫用物資的要求,公司將全力組織好相關產品生產並保證產品質量,為疫情防控做出積極貢獻。

此次備案獲批的緊急物資醫用防護服、醫用外科口罩產品,僅用於國內疫情防控應急使用,公司服從政府的調配。公司生產的應急物資產品供應數量等情況目前尚無法預測,對公司經營業績的影響還無法預計。

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