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FDA 510(k)

一次性医用检查丁腈手套 - 经化疗药物测试

K号: K220491 · 2022-05-14

申请人Hainan Asther Medical Equipment Co., Ltd.
决定日期2022-05-14
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 -Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Hainan Asther Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-05-14 under 510(k) number K220491. 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 -Tested for Use with Chemotherapy Drugs?

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2022-05-14. The listed applicant is Hainan Asther Medical Equipment Co., Ltd.. The 510(k) number is K220491.

When did Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2022-05-14, under 510(k) number K220491.

Who is the listed applicant for Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs?

The FDA 510(k) record lists Hainan Asther 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 Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs?

The FDA product code for Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs is LZC.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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CardinalhealthK243959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 BhdK220353废弃医用丁腈检查手套-用于化疗药物测试Niujian Technology Co., Ltd.

官方来源

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