FDA 510(k)

无粉乳胶手套，具有低皮炎潜力声明（蓝色）

K号: K162491 · 2017-02-08

决定日期2017-02-08

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

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdn Bhd. It received FDA 510(k) clearance on 2017-02-08 under 510(k) number K162491. 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 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)?

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a medical device that received FDA 510(k) clearance on 2017-02-08. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K162491.

When did Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) receive FDA 510(k) clearance?

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) received FDA 510(k) clearance on 2017-02-08, under 510(k) number K162491.

Who is the listed applicant for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)?

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

What is the FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)?

The FDA product code for Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is LZA.

列明Hartalega 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。

K201748天然乳胶无粉手术手套，每克手套蛋白质标注50微克或更少，并经过化疗药物使用测试 K201531无菌乳胶粉无检查手套，用于化疗药物和芬太尼盐酸盐（蓝色）K200897用于化疗药物的聚异戊二烯无粉手术手套（蓝色），用于化疗药物的自然色聚异戊二烯无粉手术手套 K180645无菌无粉检查手套，含有USP胶状燕麦和经测试可用于化疗药物 - （柠檬绿色）K180786无菌乳胶粉无检查手套，用于化疗药物测试，水蓝色（ABLU），无菌乳胶粉无检查手套，用于化疗药物测试，紫蓝色（VBLU） - 延长袖 K173509可降解乳胶检查手套，无粉，蓝色

查看所有 17 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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