FDA 510(k)

非无菌，无粉乳胶检查手套，海洋蓝，紫蓝，黑色和自然白色

K号: K212482 · 2022-08-09

申请人Sri Trang Gloves (Thailand) Public Company Limited

决定日期2022-08-09

产品代码LYY

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 Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is the device name listed in this FDA 510(k) record. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. It received FDA 510(k) clearance on 2022-08-09 under 510(k) number K212482. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White?

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is a medical device that received FDA 510(k) clearance on 2022-08-09. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K212482.

When did Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White receive FDA 510(k) clearance?

Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White received FDA 510(k) clearance on 2022-08-09, under 510(k) number K212482.

Who is the listed applicant for Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White?

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

What is the FDA product code for Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White?

The FDA product code for Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White is LYY.

列明Sri Trang Gloves (Thailand) Public Company Limited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。

K240266天然乳胶检查手套（海洋蓝和自然白）K240930非无菌，无粉丁腈检查手套，用于55种化疗药物和芬太尼测试 - 紫蓝；非无菌，无粉丁腈检查手套，用于55种化疗药物和芬太尼测试 - 蓝色 K232614非无菌，无粉丁腈检查手套，用于化疗药物和芬太尼测试（白色，黑色和紫蓝）K221165非无菌、无粉乳胶检查手套，紫色蓝色，用于化疗药物和芬太尼；非无菌、无粉乳胶检查手套，蓝色，用于化疗药物和芬太尼 K212309非无菌无粉乳胶检查手套 K200539非无菌，无粉丁腈检查手套，用于化疗药物和芬太尼测试

查看所有 8 个设备 →

相关器械（代码：LYY）

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。

K250069无菌无粉天然橡胶乳胶检查手套 - 蓝色，非灭菌，蛋白质含量声明为每dm2 50微克或以下蛋白质Comfort Rubber Gloves Industries Sdn. Bhd.K240266天然乳胶检查手套（海洋蓝和自然白）Sri Trang Gloves (Thailand) Public Company Limited K230573无菌无粉乳胶病人检查手套，黑色，非灭菌，蛋白质含量标签声明（每只手套含有50ug或更少的总可提取物蛋白质）Kossan International Sdn Bhd K223298无菌乳胶检查手套，无粉（S，M，L，超L）Shandong Intco Medical Products Co, Ltd.K222612无粉乳胶检查手套Guangdong Kingfa Sci. & Tech.Co., Ltd.K221667非无菌无粉乳胶检查手套New Era Medicare Sdn. Bhd.

官方来源

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