FDA 510(k)

BRIGHTWAY 品牌氮化橡胶检查手套 12 英寸，无粉，[紫色] 已测试用于化疗药物

K号: K162294 · 2017-04-21

决定日期2017-04-21

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

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is the device name listed in this FDA 510(k) record. The listed applicant is Brightway Holdings Sdn. Bhd.. It received FDA 510(k) clearance on 2017-04-21 under 510(k) number K162294. 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 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS?

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Brightway Holdings Sdn. Bhd.. The 510(k) number is K162294.

When did BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS receive FDA 510(k) clearance?

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS received FDA 510(k) clearance on 2017-04-21, under 510(k) number K162294.

Who is the listed applicant for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS?

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

What is the FDA product code for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS?

The FDA product code for BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS is LZA.

列明Brightway 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。

K211816Brightway品牌，乳胶检查手套，无粉（蓝色）用于化疗药物和芬太尼测试 K170686丁腈检查手套，无粉[紫色]用于化疗药物测试 K162186BRIGHTWAY 品牌氮化橡胶检查手套 12 英寸，无粉，[银色/灰色] 具有化疗声明 K163267NITRILE EXAMINATION GLOVE K162146Brightway品牌乳胶检查手套，无粉（薰衣草）K161215Brightway品牌乳胶检查手套，无粉，[Sterling/Grey] 用于化疗药物测试

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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