FDA 510(k)

丁腈手套无粉黑色

K号: K182528 · 2018-11-15

决定日期2018-11-15

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

Nitrile Glove Powder Free Black is the device name listed in this FDA 510(k) record. The listed applicant is Haining Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K182528. 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 Nitrile Glove Powder Free Black?

Nitrile Glove Powder Free Black is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Haining Medical Products Co., Ltd.. The 510(k) number is K182528.

When did Nitrile Glove Powder Free Black receive FDA 510(k) clearance?

Nitrile Glove Powder Free Black received FDA 510(k) clearance on 2018-11-15, under 510(k) number K182528.

Who is the listed applicant for Nitrile Glove Powder Free Black?

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

What is the FDA product code for Nitrile Glove Powder Free Black?

The FDA product code for Nitrile Glove Powder Free Black is LZA.

列明Haining Medical Products 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。

K183068丁腈手套无粉白色 K152715HAINING 氮化物无粉患者检查手套，蓝色

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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