FDA 510(k)

患者检查手套

K号: K230777 · 2023-10-06

决定日期2023-10-06

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

Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is 3A Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K230777. 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 Patient Examination Gloves?

Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is 3A Glove Sdn. Bhd.. The 510(k) number is K230777.

When did Patient Examination Gloves receive FDA 510(k) clearance?

Patient Examination Gloves received FDA 510(k) clearance on 2023-10-06, under 510(k) number K230777.

Who is the listed applicant for Patient Examination Gloves?

The FDA 510(k) record lists 3A Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Patient Examination Gloves?

The FDA product code for Patient Examination Gloves is LZA.

列明3A Glove 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。

K230847化疗手套

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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