无粉聚氯乙烯检查手套，透明
K号: K252505 · 2025-08-28
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决定日期2025-08-28
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
Powder-Free Vinyl Exam Gloves, clear is the device name listed in this FDA 510(k) record. The listed applicant is Basic Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K252505. 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 Powder-Free Vinyl Exam Gloves, clear?
Powder-Free Vinyl Exam Gloves, clear is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Basic Medical Technology, Inc.. The 510(k) number is K252505.
When did Powder-Free Vinyl Exam Gloves, clear receive FDA 510(k) clearance?
Powder-Free Vinyl Exam Gloves, clear received FDA 510(k) clearance on 2025-08-28, under 510(k) number K252505.
Who is the listed applicant for Powder-Free Vinyl Exam Gloves, clear?
The FDA 510(k) record lists Basic Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Powder-Free Vinyl Exam Gloves, clear?
The FDA product code for Powder-Free Vinyl Exam Gloves, clear 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Basic Medical Technology, Inc.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.K241252一次性乙烯基检查手套Anqing Pukang Medical Technology Co., Ltd.K230046乙烯基检查手套Guangdong Kingfa Sci. & Tech.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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