FDA 510(k)

Penta 手套

K号: K212847 · 2022-01-06

决定日期2022-01-06

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

Penta Glove is the device name listed in this FDA 510(k) record. The listed applicant is Pentavest Holdings Sdn Bhd. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K212847. 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 Penta Glove?

Penta Glove is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Pentavest Holdings Sdn Bhd. The 510(k) number is K212847.

When did Penta Glove receive FDA 510(k) clearance?

Penta Glove received FDA 510(k) clearance on 2022-01-06, under 510(k) number K212847.

Who is the listed applicant for Penta Glove?

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

What is the FDA product code for Penta Glove?

The FDA product code for Penta Glove is LZA.

列明Pentavest Holdings 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。

K212848无菌乳胶手术手套，无粉

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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