FDA 510(k)

Iconic蓝丁腈手套 - 经测试可用于化疗药物及芬太尼盐酸盐

K号: K222181 · 2023-01-11

决定日期2023-01-11

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

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Iconic Medicare Sdn Bhd. It received FDA 510(k) clearance on 2023-01-11 under 510(k) number K222181. 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 Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2023-01-11. The listed applicant is Iconic Medicare Sdn Bhd. The 510(k) number is K222181.

When did Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate receive FDA 510(k) clearance?

Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate received FDA 510(k) clearance on 2023-01-11, under 510(k) number K222181.

Who is the listed applicant for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

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

What is the FDA product code for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate?

The FDA product code for Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate is LZA.

列明Iconic Medicare Sdn Bhd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。

K221648Iconic乳胶手套 K212182Iconic丁腈手套

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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