FDA 510(k)

蓝色丁腈无粉患者检查手套，非无菌

K号: K210366 · 2021-05-07

决定日期2021-05-07

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

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Onetexx Sdn Bhd. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K210366. 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 Blue Nitrile Powder Free Patient Examination Glove, Non Sterile?

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Onetexx Sdn Bhd. The 510(k) number is K210366.

When did Blue Nitrile Powder Free Patient Examination Glove, Non Sterile receive FDA 510(k) clearance?

Blue Nitrile Powder Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2021-05-07, under 510(k) number K210366.

Who is the listed applicant for Blue Nitrile Powder Free Patient Examination Glove, Non Sterile?

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

What is the FDA product code for Blue Nitrile Powder Free Patient Examination Glove, Non Sterile?

The FDA product code for Blue Nitrile Powder Free Patient Examination Glove, Non Sterile is LZA.

列明Onetexx 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。

K222298紫罗兰丁腈粉未免洗手套，非无菌，适用于与化疗药物、芬太尼盐酸盐、模拟胃酸和胃酸中的芬太尼使用测试。K222294黑色乳胶无粉患者检查手套，非无菌，用于化疗药物，阿片类药物芬太尼盐酸盐，模拟胃酸和胃酸中的芬太尼 K221773蓝色丁腈无粉患者检查手套，非无菌，经芬太尼柠檬酸盐、模拟胃酸和胃酸中芬太尼使用测试 K210588黑色乳胶无粉患者检查手套，非无菌 K210775白色乳胶粉末免费患者检查手套，非无菌 K210587紫罗兰丁腈粉末无粉患者检查手套，非无菌

查看所有 7 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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