FDA 510(k)

Medline 粉末-free 浅蓝色硅橡胶检查手套（经测试可用于化疗药物）

K号: K201390 · 2020-09-18

决定日期2020-09-18

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

Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industires, Inc.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K201390. 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 Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)?

Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Medline Industires, Inc.. The 510(k) number is K201390.

When did Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2020-09-18, under 510(k) number K201390.

Who is the listed applicant for Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA 510(k) record lists Medline Industires, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) is LZC.

列明Medline Industires, Inc.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。

K220955Hudson RCI Variable浓度大容量雾化器（1770）K201129Medline 烟雾抽吸笔 K200960Medline 粉末-free 检查手套（经测试可用于化疗药物）K201319Medline UNITE Jones骨折螺钉系统

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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