免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

无粉乳胶检查手套，聚合物涂层

K号: K170094 · 2017-06-23

申请人Vietglove Corporation
决定日期2017-06-23
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

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED is the device name listed in this FDA 510(k) record. The listed applicant is Vietglove Corporation. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K170094. 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 POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED?

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Vietglove Corporation. The 510(k) number is K170094.

When did POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED receive FDA 510(k) clearance?

POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED received FDA 510(k) clearance on 2017-06-23, under 510(k) number K170094.

Who is the listed applicant for POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED?

The FDA 510(k) record lists Vietglove Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED?

The FDA product code for POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED 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

列明Vietglove Corporation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。

K201428Powder Free Black Nitrile Examination GloveK162175无菌无粉乳胶检查手套，蛋白质含量标签声明为50ug/dm2或以下K153562无菌无粉蓝色丁腈检查手套

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。

↑