乙烯基检查手套
K号: K230046 · 2023-03-25
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决定日期2023-03-25
产品代码LYZ
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
Vinyl examination gloves is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2023-03-25 under 510(k) number K230046. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Vinyl examination gloves?
Vinyl examination gloves is a medical device that received FDA 510(k) clearance on 2023-03-25. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K230046.
When did Vinyl examination gloves receive FDA 510(k) clearance?
Vinyl examination gloves received FDA 510(k) clearance on 2023-03-25, under 510(k) number K230046.
Who is the listed applicant for Vinyl examination gloves?
The FDA 510(k) record lists Guangdong Kingfa Sci. & Tech.Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vinyl examination gloves?
The FDA product code for Vinyl examination gloves is LYZ.
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Guangdong Kingfa Sci. & Tech.Co., Ltd.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：LYZ）
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。
K260860无粉合成氯乙烯检查手套（蓝色，黑色）Basic Medical Technology, Inc.K252467一次性乙烯基检查手套Viet Phu Trade and Import Export Co., Ltd.K252505无粉聚氯乙烯检查手套，透明Basic Medical Technology, Inc.K241252一次性乙烯基检查手套Anqing Pukang Medical Technology Co., Ltd.K221980一次性无粉聚氯乙烯检查手套，米色/透明Ever Global (Vietnam) Enterprise CorporationK220992一次性无粉聚氯乙烯检查手套，黑色/蓝色/紫色Ever Global (Vietnam) Enterprise Corporation
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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