无粉乳胶检查手套
K号: K173053 · 2018-06-06
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决定日期2018-06-06
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 is the device name listed in this FDA 510(k) record. The listed applicant is Professional Latex Sdn Bhd. It received FDA 510(k) clearance on 2018-06-06 under 510(k) number K173053. 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?
POWDER FREE LATEX EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Professional Latex Sdn Bhd. The 510(k) number is K173053.
When did POWDER FREE LATEX EXAMINATION GLOVE receive FDA 510(k) clearance?
POWDER FREE LATEX EXAMINATION GLOVE received FDA 510(k) clearance on 2018-06-06, under 510(k) number K173053.
Who is the listed applicant for POWDER FREE LATEX EXAMINATION GLOVE?
The FDA 510(k) record lists Professional Latex Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for POWDER FREE LATEX EXAMINATION GLOVE?
The FDA product code for POWDER FREE LATEX EXAMINATION 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Professional Latex 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。
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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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