FDA 510(k)

NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST

K号: K162858 · 2017-07-24

决定日期2017-07-24

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

NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST is the device name listed in this FDA 510(k) record. The listed applicant is Careplus (M) Sdn Bhd. It received FDA 510(k) clearance on 2017-07-24 under 510(k) number K162858. 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 NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST?

NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST is a medical device that received FDA 510(k) clearance on 2017-07-24. The listed applicant is Careplus (M) Sdn Bhd. The 510(k) number is K162858.

When did NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST receive FDA 510(k) clearance?

NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST received FDA 510(k) clearance on 2017-07-24, under 510(k) number K162858.

Who is the listed applicant for NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST?

The FDA 510(k) record lists Careplus (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST?

The FDA product code for NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST is LZC.

列明Careplus (M) 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。

K211621天然乳胶外科手套，无粉，蛋白质含量标注（50微克或更少）K201857无粉乳胶检查手套黑色和双色白-蓝 K203705天然乳胶检查手套，无粉，蛋白质含量标注（每克总可提取物蛋白质50ug或更少）K210724ENCORE Latex Acclaim，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套50ug/dm2的总水溶性蛋白）并经过化疗药物使用测试，GAMMEX Latex Standard，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套50ug/dm2的总水溶性蛋白）并经过化疗药物使用测试 K210656ENCORE Latex Ortho，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套<50µg/dm2的总水溶性蛋白）并经过化疗药物使用测试，GAMMEX Latex Ortho，无粉乳胶外科手套，带有蛋白质含量标签声明（每只手套<50 µg/dm2的总水溶性蛋白）并经过化疗药物使用测试 K202765ENCORE Latex Textured Surgical Gloves，无粉，带有蛋白质含量标签声明（50微克或更少）并经过化疗药物使用测试

查看所有 8 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.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。