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FDA 510(k)

First Glove Blue Nitrile Examination Gloves Powder Free

K号: K230958 · 2023-05-30

申请人First Glove Sdn. Bhd.
决定日期2023-05-30
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

First Glove Blue Nitrile Examination Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is First Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K230958. 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 First Glove Blue Nitrile Examination Gloves Powder Free?

First Glove Blue Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is First Glove Sdn. Bhd.. The 510(k) number is K230958.

When did First Glove Blue Nitrile Examination Gloves Powder Free receive FDA 510(k) clearance?

First Glove Blue Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2023-05-30, under 510(k) number K230958.

Who is the listed applicant for First Glove Blue Nitrile Examination Gloves Powder Free?

The FDA 510(k) record lists First Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for First Glove Blue Nitrile Examination Gloves Powder Free?

The FDA product code for First Glove Blue Nitrile Examination Gloves Powder Free is LZA.

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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

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