FDA 510(k)

一次性医用合成丁腈检查手套（非无菌）

K号: K211667 · 2021-09-23

申请人Changzhou Universal Medical Equipment Co., Ltd.

决定日期2021-09-23

产品代码LAZ

咨询委员会TX 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K211667. The device is classified under product code LAZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Changzhou Universal Medical Equipment Co., Ltd.. The 510(k) number is K211667.

When did Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) receive FDA 510(k) clearance?

Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K211667.

Who is the listed applicant for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

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

What is the FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)?

The FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) is LAZ.

列明Changzhou Universal Medical Equipment 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。

K213910一次性医用检查丁腈手套 - 经化疗药物测试 K210145丁腈手套无粉蓝色

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

相关临床试验

列明Changzhou Universal Medical Equipment Co., Ltd.为申报人的其他记录

官方来源