FDA 510(k)

Rhino非灭菌、无粉乳胶检查手套 - 天蓝色测试用于化疗药物和芬太尼

K号: K221082 · 2022-11-30

决定日期2022-11-30

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

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Rhino Health, Inc.. It received FDA 510(k) clearance on 2022-11-30 under 510(k) number K221082. 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 Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl is a medical device that received FDA 510(k) clearance on 2022-11-30. The listed applicant is Rhino Health, Inc.. The 510(k) number is K221082.

When did Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl receive FDA 510(k) clearance?

Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl received FDA 510(k) clearance on 2022-11-30, under 510(k) number K221082.

Who is the listed applicant for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

The FDA 510(k) record lists Rhino Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl?

The FDA product code for Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl is LZA.

列明Rhino Health, 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。

K223859Rhino 无菌粉末型乳胶检查手套 – 雪青色已测试用于化疗药物和芬太尼 K203236Rhino非灭菌、无粉乳胶检查手套

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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