FDA 510(k)

无菌粉无乳胶检查手套（蓝色、黑色和白色）

K号: K230314 · 2023-08-16

决定日期2023-08-16

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

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) is the device name listed in this FDA 510(k) record. The listed applicant is New Era Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K230314. 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 Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)?

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is New Era Medicare Sdn. Bhd.. The 510(k) number is K230314.

When did Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) receive FDA 510(k) clearance?

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) received FDA 510(k) clearance on 2023-08-16, under 510(k) number K230314.

Who is the listed applicant for Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)?

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

What is the FDA product code for Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)?

The FDA product code for Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) is LZA.

列明New Era Medicare 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。

K221424无菌无粉乳胶外科手套 K221667非无菌无粉乳胶检查手套

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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