FDA 510(k)

非无菌，无粉丁腈检查手套，黑色，用于化疗药物测试

K号: K182241 · 2019-03-11

申请人Sri Trang Gloves (Thailand) Co., Ltd.

决定日期2019-03-11

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

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Sri Trang Gloves (Thailand) Co., Ltd.. It received FDA 510(k) clearance on 2019-03-11 under 510(k) number K182241. 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 Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-03-11. The listed applicant is Sri Trang Gloves (Thailand) Co., Ltd.. The 510(k) number is K182241.

When did Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs receive FDA 510(k) clearance?

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2019-03-11, under 510(k) number K182241.

Who is the listed applicant for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

The FDA 510(k) record lists Sri Trang Gloves (Thailand) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

The FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is LZA.

列明Sri Trang Gloves (Thailand) Co., Ltd.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。

K182308非灭菌，无粉乳胶检查手套粉红色，用于化疗药物

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。

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