FDA 510(k)

无粉乳胶检查手套

K号: K222612 · 2022-11-25

申请人Guangdong Kingfa Sci. & Tech.Co., Ltd.

决定日期2022-11-25

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

Powder-Free Latex examination gloves is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2022-11-25 under 510(k) number K222612. 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 Powder-Free Latex examination gloves?

Powder-Free Latex examination gloves is a medical device that received FDA 510(k) clearance on 2022-11-25. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K222612.

When did Powder-Free Latex examination gloves receive FDA 510(k) clearance?

Powder-Free Latex examination gloves received FDA 510(k) clearance on 2022-11-25, under 510(k) number K222612.

Who is the listed applicant for Powder-Free Latex examination gloves?

The FDA 510(k) record lists Guangdong Kingfa Sci. & Tech.Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder-Free Latex examination gloves?

The FDA product code for Powder-Free Latex examination gloves is LYY.

列明Guangdong Kingfa Sci. & Tech.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。

K233723医用外科口罩 K231155可降解医用外科口罩 K221983可降解无粉乳胶检查手套，蓝色，可降解无粉乳胶检查手套，蓝紫色，可降解无粉乳胶检查手套，绿色 K230046乙烯基检查手套 K222714丁腈患者检查手套蓝色，用于化疗药物测试，丁腈患者检查手套蓝色紫罗兰色，用于化疗药物测试，丁腈患者检查手套黑色，用于化疗药物测试 K221887丙烯酸丁腈检查手套，粉色；丙烯酸丁腈检查手套，黑色；丙烯酸丁腈检查手套，白色

查看所有 14 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.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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