丁腈手套（型号：NE01）
K号: K212840 · 2021-12-11
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决定日期2021-12-11
产品代码LZA
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
Nitrile Gloves (Model: NE01) is the device name listed in this FDA 510(k) record. The listed applicant is Byd Auto Industry Company Limited. It received FDA 510(k) clearance on 2021-12-11 under 510(k) number K212840. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Nitrile Gloves (Model: NE01)?
Nitrile Gloves (Model: NE01) is a medical device that received FDA 510(k) clearance on 2021-12-11. The listed applicant is Byd Auto Industry Company Limited. The 510(k) number is K212840.
When did Nitrile Gloves (Model: NE01) receive FDA 510(k) clearance?
Nitrile Gloves (Model: NE01) received FDA 510(k) clearance on 2021-12-11, under 510(k) number K212840.
Who is the listed applicant for Nitrile Gloves (Model: NE01)?
The FDA 510(k) record lists Byd Auto Industry Company Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nitrile Gloves (Model: NE01)?
The FDA product code for Nitrile Gloves (Model: NE01) is LZA.
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。
相关器械（代码：LZA）
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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