FDA 510(k)

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）

K号: K222449 · 2022-08-27

申请人Better Care Plastic Technology Co., Ltd.

决定日期2022-08-27

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

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Better Care Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-27 under 510(k) number K222449. 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 Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)?

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) is a medical device that received FDA 510(k) clearance on 2022-08-27. The listed applicant is Better Care Plastic Technology Co., Ltd.. The 510(k) number is K222449.

When did Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) received FDA 510(k) clearance on 2022-08-27, under 510(k) number K222449.

Who is the listed applicant for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)?

The FDA 510(k) record lists Better Care Plastic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)?

The FDA product code for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) is LZC.

列明Better Care Plastic Technology 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。

K242533无粉乳胶患者检查手套，蓝色，非无菌，低皮炎潜力。经过与化疗药物和芬太尼使用的测试 K232266无粉乳胶患者检查手套，蓝色，非无菌，经过与化疗药物和芬太尼使用的测试 K232070用于与化疗药物和芬太尼盐酸盐（黑色，绿色）使用的可降解乳胶检查手套 K231567用于与化疗药物、芬太尼盐酸盐和选定的其他药物使用的可降解乳胶检查手套，无粉（蓝色）K223713无菌无粉丁腈检查手套（灰色）经测试可用于化疗药物和芬太尼柠檬酸盐 K221269无粉乳胶检查手套（蓝色），经测试可用于化疗药物和芬太尼柠檬酸盐

查看所有 10 个设备 →

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.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.K220353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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