FDA 510(k)

天然乳胶检查手套（海洋蓝和自然白）

K号: K240266 · 2024-09-09

申请人Sri Trang Gloves (Thailand) Public Company Limited

决定日期2024-09-09

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

Latex Examination Glove Powder Free (Ocean Blue 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 2024-09-09 under 510(k) number K240266. 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 Latex Examination Glove Powder Free (Ocean Blue and Natural White)?

Latex Examination Glove Powder Free (Ocean Blue and Natural White) is a medical device that received FDA 510(k) clearance on 2024-09-09. The listed applicant is Sri Trang Gloves (Thailand) Public Company Limited. The 510(k) number is K240266.

When did Latex Examination Glove Powder Free (Ocean Blue and Natural White) receive FDA 510(k) clearance?

Latex Examination Glove Powder Free (Ocean Blue and Natural White) received FDA 510(k) clearance on 2024-09-09, under 510(k) number K240266.

Who is the listed applicant for Latex Examination Glove Powder Free (Ocean Blue 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 Latex Examination Glove Powder Free (Ocean Blue and Natural White)?

The FDA product code for Latex Examination Glove Powder Free (Ocean Blue 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。

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 K212482非无菌，无粉乳胶检查手套，海洋蓝，紫蓝，黑色和自然白色 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.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.K222348JR MEDICJr Engineering & Medical Technologies (M) Sdn. Bhd.

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。