FDA 510(k)

乳胶蓝无粉检查手套，具有低皮炎潜力声明，并经化疗药物使用测试

K号: K163017 · 2017-03-22

决定日期2017-03-22

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 Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Gmp Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K163017. 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 Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs?

Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Gmp Medicare Sdn. Bhd.. The 510(k) number is K163017.

When did Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2017-03-22, under 510(k) number K163017.

Who is the listed applicant for Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs?

FDA 510(k)记录将Gmp Medicare Sdn. Bhd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs?

The FDA product code for Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs is LZC.

列明Gmp Medicare Sdn. Bhd.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。

K260312氰化物粉末免费检查手套，蓝色；经测试可用于32种化疗药物和芬太尼渗透阻力；氰化物粉末免费检查手套，紫蓝色；经测试可用于32种化疗药物、盐酸氯丙嗪、芬太尼和胃酸 K250944无粉乳胶手套，蓝色，经测试可用于60种化疗药物、胃酸、盐酸氯丙嗪和芬太尼 K202003无粉乳胶手套，蓝色，经测试可用于32种化疗药物和芬太尼渗透阻力声明

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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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。