FDA 510(k)

PF 硝基橡胶检查手套，黑色-灰色，经测试可用于化疗药物

K号: K173766 · 2018-07-08

决定日期2018-07-08

产品代码LZC

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

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Shen Wei USA, Inc.. It received FDA 510(k) clearance on 2018-07-08 under 510(k) number K173766. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is a medical device that received FDA 510(k) clearance on 2018-07-08. The listed applicant is Shen Wei USA, Inc.. The 510(k) number is K173766.

When did PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs receive FDA 510(k) clearance?

PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs received FDA 510(k) clearance on 2018-07-08, under 510(k) number K173766.

Who is the listed applicant for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

The FDA 510(k) record lists Shen Wei USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs?

The FDA product code for PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs is LZC.

列明Shen Wei USA, Inc.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。

K213141可生物降解的无粉乳胶检查手套，蓝色和绿色，低皮炎潜力，经测试可用于化疗药物、芬太尼盐酸盐、模拟胃酸和芬太尼盐酸盐-模拟胃酸溶液的使用 K213142可降解无粉绒毛衬里乳胶检查手套，黑色和灰色，用于化疗药物、芬太尼盐酸盐、模拟胃酸和芬太尼盐酸盐模拟胃酸溶液的测试 K213144可生物降解的无粉聚氯乙烯检查手套，蓝色、绿色和白色 K211620可降解无粉天然乳胶检查手套，蛋白质含量标签声明（50微克或以下），蓝色、黑色和绿色 K211455无粉乳胶检查手套，含有芦荟、橙色和橙白色 K202085可降解无粉氯丁橡胶检查手套，低皮炎潜力声明，绿色

查看所有 19 个设备 →

相关器械（代码：LZC）

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。

K252313Cardinal Health 氮化橡胶检查手套，延长袖口Cardinalhealth K243959无尘乳胶检查手套（紫色，黑色，绿色），经测试可用于化疗药物，芬太尼盐酸盐和选定的其他药物Lingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449丁腈粉末无粉检查手套，经测试可用于化疗药物和芬太尼盐酸盐（深蓝色）Better Care Plastic Technology Co., Ltd.K220545无粉乳胶检查手套，蓝色，用于化疗药物测试Hl Rubber Industries Sdn Bhd K220491一次性医用检查丁腈手套 - 经化疗药物测试Hainan Asther Medical Equipment Co., Ltd.

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。