FDA 510(k)

HALYARD* PURPLE NITRILE – XTRA* 无粉检查手套

K号: K160709 · 2016-09-06

决定日期2016-09-06

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

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K160709. 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 HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves?

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Halyard Health. The 510(k) number is K160709.

When did HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves receive FDA 510(k) clearance?

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves received FDA 510(k) clearance on 2016-09-06, under 510(k) number K160709.

Who is the listed applicant for HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves?

The FDA 510(k) record lists Halyard Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves?

The FDA product code for HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves is LZC.

列明Halyard Health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。

K181360ON-Q* Pump with Bolus K180646Halyard 紫罗兰色乳胶无粉检查手套，经化疗药物测试 K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit K153708Halyard 黑橙色无粉乳胶检查手套

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.

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