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FDA 510(k)

Glovatex™ 白色天然乳胶手套，Glovanil™ 蓝色丁腈手套

K号: K213775 · 2022-04-24

申请人Avecena Gloves Sdn Bhd
决定日期2022-04-24
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。
决定实质等同

器械摘要

Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Avecena Gloves Sdn Bhd. It received FDA 510(k) clearance on 2022-04-24 under 510(k) number K213775. 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 Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves?

Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves is a medical device that received FDA 510(k) clearance on 2022-04-24. The listed applicant is Avecena Gloves Sdn Bhd. The 510(k) number is K213775.

When did Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves receive FDA 510(k) clearance?

Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves received FDA 510(k) clearance on 2022-04-24, under 510(k) number K213775.

Who is the listed applicant for Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves?

The FDA 510(k) record lists Avecena Gloves Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves?

The FDA product code for Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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

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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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