Iconic乳胶手套
K号: K221648 · 2022-08-25
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决定日期2022-08-25
产品代码LYY
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
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器械摘要
Iconic Latex Glove is the device name listed in this FDA 510(k) record. The listed applicant is Iconic Medicare Sdn Bhd. It received FDA 510(k) clearance on 2022-08-25 under 510(k) number K221648. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Iconic Latex Glove?
Iconic Latex Glove is a medical device that received FDA 510(k) clearance on 2022-08-25. The listed applicant is Iconic Medicare Sdn Bhd. The 510(k) number is K221648.
When did Iconic Latex Glove receive FDA 510(k) clearance?
Iconic Latex Glove received FDA 510(k) clearance on 2022-08-25, under 510(k) number K221648.
Who is the listed applicant for Iconic Latex Glove?
The FDA 510(k) record lists Iconic Medicare Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Iconic Latex Glove?
The FDA product code for Iconic Latex Glove is LYY.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Iconic Medicare Sdn Bhd为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：LYY）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K250069无菌无粉天然橡胶乳胶检查手套 - 蓝色，非灭菌，蛋白质含量声明为每dm2 50微克或以下蛋白质Comfort Rubber Gloves Industries Sdn. Bhd.K240266天然乳胶检查手套（海洋蓝和自然白）Sri Trang Gloves (Thailand) Public Company LimitedK230573无菌无粉乳胶病人检查手套，黑色，非灭菌，蛋白质含量标签声明（每只手套含有50ug或更少的总可提取物蛋白质）Kossan International Sdn BhdK223298无菌乳胶检查手套，无粉（S，M，L，超L）Shandong Intco Medical Products Co, Ltd.K222612无粉乳胶检查手套Guangdong Kingfa Sci. & Tech.Co., Ltd.K221667非无菌无粉乳胶检查手套New Era Medicare Sdn. Bhd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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