FDA 510(k)

一次性医用检查丁腈手套（非无菌）

K号: K212639 · 2021-12-08

决定日期2021-12-08

产品代码LZC

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 Medical Nitrile Examination Gloves (Non sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Nanfang Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-12-08 under 510(k) number K212639. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Disposable Medical Nitrile Examination Gloves (Non sterile)?

Disposable Medical Nitrile Examination Gloves (Non sterile) is a medical device that received FDA 510(k) clearance on 2021-12-08. The listed applicant is Jiangsu Nanfang Medical Co., Ltd.. The 510(k) number is K212639.

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

Disposable Medical Nitrile Examination Gloves (Non sterile) received FDA 510(k) clearance on 2021-12-08, under 510(k) number K212639.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves (Non sterile)?

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

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

The FDA product code for Disposable Medical Nitrile Examination Gloves (Non sterile) is LZC.

列明Jiangsu Nanfang Medical 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。

K212826一次性医用口罩

相关器械（代码：LZC）

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。

K252313Cardinal Health 氮化橡胶检查手套，延长袖口Cardinalhealth K243959无尘乳胶检查手套（紫色，黑色，绿色），经测试可用于化疗药物，芬太尼盐酸盐和选定的其他药物Lingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449丁腈粉末无粉检查手套，经测试可用于化疗药物和芬太尼盐酸盐（深蓝色）Better Care Plastic Technology Co., Ltd.K220545无粉乳胶检查手套，蓝色，用于化疗药物测试Hl Rubber Industries Sdn Bhd K220491一次性医用检查丁腈手套 - 经化疗药物测试Hainan Asther Medical Equipment Co., Ltd.

官方来源

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