FDA 510(k)

Palm Care Blue Nitrile 检查手套无粉

K号: K202384 · 2020-12-02

决定日期2020-12-02

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

Palm Care Blue Nitrile Examination Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Care Thai Gloves Co. , Ltd.. It received FDA 510(k) clearance on 2020-12-02 under 510(k) number K202384. 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 Palm Care Blue Nitrile Examination Gloves Powder Free?

Palm Care Blue Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2020-12-02. The listed applicant is Hi-Care Thai Gloves Co. , Ltd.. The 510(k) number is K202384.

When did Palm Care Blue Nitrile Examination Gloves Powder Free receive FDA 510(k) clearance?

Palm Care Blue Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2020-12-02, under 510(k) number K202384.

Who is the listed applicant for Palm Care Blue Nitrile Examination Gloves Powder Free?

The FDA 510(k) record lists Hi-Care Thai Gloves Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Palm Care Blue Nitrile Examination Gloves Powder Free?

The FDA product code for Palm Care Blue Nitrile Examination Gloves Powder Free is LZA.

列明Hi-Care Thai Gloves 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。

K202377Palm Care 橡胶检查手套无粉

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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