FDA 510(k)

一次性乳胶检查手套（非无菌），一次性丁腈检查手套（非无菌）

K号: K203074 · 2021-11-19

决定日期2021-11-19

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

Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Universal Gloves. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K203074. 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 Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)?

Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Pt. Universal Gloves. The 510(k) number is K203074.

When did Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) receive FDA 510(k) clearance?

Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) received FDA 510(k) clearance on 2021-11-19, under 510(k) number K203074.

Who is the listed applicant for Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)?

The FDA 510(k) record lists Pt. Universal Gloves as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)?

The FDA product code for Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) is LYY.

列明Pt. Universal Gloves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。

K211360一次性乳胶无粉检查手套（非无菌）K201576一次性乳胶无粉检查手套（非无菌）

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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