FDA 510(k)

一次性乳胶医疗检查手套（经化疗药物使用测试）

K号: K212834 · 2021-12-30

申请人Siyang Threeguard Medical Supplies Co., Ltd.

决定日期2021-12-30

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

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Siyang Threeguard Medical Supplies Co., Ltd.. It received FDA 510(k) clearance on 2021-12-30 under 510(k) number K212834. 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 Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)?

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-12-30. The listed applicant is Siyang Threeguard Medical Supplies Co., Ltd.. The 510(k) number is K212834.

When did Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-12-30, under 510(k) number K212834.

Who is the listed applicant for Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)?

The FDA 510(k) record lists Siyang Threeguard Medical Supplies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) is LZA.

列明Siyang Threeguard Medical Supplies Co., Ltd.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。

K211131一次性乳胶医疗检查手套

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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