FDA 510(k)

Nephron Nitrile™, Nitrile 无粉检验黑手套（经测试可用于化疗药物和芬太尼）

K号: K232654 · 2024-03-20

决定日期2024-03-20

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

Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) is the device name listed in this FDA 510(k) record. The listed applicant is Nephron Nitrile, LLC. It received FDA 510(k) clearance on 2024-03-20 under 510(k) number K232654. 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 Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)?

Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) is a medical device that received FDA 510(k) clearance on 2024-03-20. The listed applicant is Nephron Nitrile, LLC. The 510(k) number is K232654.

When did Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) receive FDA 510(k) clearance?

Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) received FDA 510(k) clearance on 2024-03-20, under 510(k) number K232654.

Who is the listed applicant for Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)?

The FDA 510(k) record lists Nephron Nitrile, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)?

The FDA product code for Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) is LZA.

列明Nephron Nitrile, LLC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。

K233970Nephron Nitrile™, Nitrile 无粉检验蓝手套（经测试可用于化疗药物和芬太尼）K231349Nephron 氮化丁腈无粉乳胶检查手套（用于化疗药物和芬太尼的测试）

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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