FDA 510(k)

AspenMed+

K号: K213076 · 2021-12-20

决定日期2021-12-20

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

AspenMed+ is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2021-12-20 under 510(k) number K213076. 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 AspenMed+?

AspenMed+ is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is Aspen Glove Sdn. Bhd.. The 510(k) number is K213076.

When did AspenMed+ receive FDA 510(k) clearance?

AspenMed+ received FDA 510(k) clearance on 2021-12-20, under 510(k) number K213076.

Who is the listed applicant for AspenMed+?

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

What is the FDA product code for AspenMed+?

The FDA product code for AspenMed+ is LZC.

列明Aspen Glove 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。

K211477天然乳胶无粉检查手套 K211479蓝色丁腈检查手套，无粉 K211478无菌乳胶手术手套，无粉

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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