FDA 510(k)

PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves

K号: K220547 · 2022-06-02

决定日期2022-06-02

产品代码LZA

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

PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2022-06-02 under 510(k) number K220547. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves?

PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves is a medical device that received FDA 510(k) clearance on 2022-06-02. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K220547.

When did PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves receive FDA 510(k) clearance?

PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves received FDA 510(k) clearance on 2022-06-02, under 510(k) number K220547.

Who is the listed applicant for PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves?

FDA 510(k)记录中列出O&M Halyard, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves?

The FDA product code for PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves is LZA.

列明O&M Halyard, 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。

K262014PUREZERO* MARIN* 硅橡胶无粉检查手套；PUREZERO* MARIN-XTRA* 硅橡胶无粉检查手套 K261897HALYARD* ARMOR-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* HEAVY-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* STANDARD-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* H300W 消毒包裹带 ASSURE-DRY* 技术 K253454HALYARD* ONE-STEP* 消毒包裹；HALYARD* QUICK CHECK* 消毒包裹；HALYARD* SEQUENTIAL 消毒包裹；HALYARD* SMART-FOLD* 消毒包裹 K251967HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带；HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，带有 WrapAround 护目镜 K252941HALYARD* 成人面部口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带 K243604Halyard紫色丁腈-XTRA*无粉手套，低皮炎潜力，用于化疗药物，芬太尼盐酸盐和模拟胃酸中的芬太尼盐酸盐

查看所有 26 个设备 →

相关器械（代码：LZA）

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。

K261793无粉乳胶检查手套，适用于化疗药物和芬太尼盐酸盐（蓝色和黑色）使用测试Maxter Healthcare, Inc.K262542可生物降解的尼龙粉末免洗检查手套，绿色；可生物降解的尼龙粉末免洗检查手套，紫蓝色；经测试可用于32种化疗药物、芬太尼和胃酸渗透阻力声明Top Glove Sdn. Bhd.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Gmp Medicare Sdn. Bhd.K261749Cardinal Health 硝基蓝检查手套，经测试可用于化疗药物和芬太尼盐酸盐使用Cardinalhealth K260794非无菌无粉乳胶患者检查手套，含有甘草根提取物和尿素，经测试可用于化疗药物、芬太尼柠檬酸盐、盐酸氯丙嗪和胃酸。海洋色Kossan International Sdn Bhd K262014PUREZERO* MARIN* 硅橡胶无粉检查手套；PUREZERO* MARIN-XTRA* 硅橡胶无粉检查手套O&M Halyard, Inc.

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。