FDA 510(k)

Palm Care 橡胶检查手套无粉

K号: K202377 · 2020-12-01

决定日期2020-12-01

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

Palm Care Latex Examination Powder Free Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Care Thai Gloves Co. , Ltd.. It received FDA 510(k) clearance on 2020-12-01 under 510(k) number K202377. 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 Palm Care Latex Examination Powder Free Gloves?

Palm Care Latex Examination Powder Free Gloves is a medical device that received FDA 510(k) clearance on 2020-12-01. The listed applicant is Hi-Care Thai Gloves Co. , Ltd.. The 510(k) number is K202377.

When did Palm Care Latex Examination Powder Free Gloves receive FDA 510(k) clearance?

Palm Care Latex Examination Powder Free Gloves received FDA 510(k) clearance on 2020-12-01, under 510(k) number K202377.

Who is the listed applicant for Palm Care Latex Examination Powder Free Gloves?

The FDA 510(k) record lists Hi-Care Thai Gloves Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Palm Care Latex Examination Powder Free Gloves?

The FDA product code for Palm Care Latex Examination Powder Free Gloves is LYY.

列明Hi-Care Thai Gloves 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。

K202384Palm Care Blue Nitrile 检查手套无粉

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

在 FDA 数据库中查看 →

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。