FDA 510(k)

乙烯基病人检查手套

K号: K182115 · 2018-10-03

决定日期2018-10-03

产品代码LYZ

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决定实质等同

器械摘要

Vinyl Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Pingan Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2018-10-03 under 510(k) number K182115. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vinyl Patient Examination Gloves?

Vinyl Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2018-10-03. The listed applicant is Pingan Medical Products Co., Ltd.. The 510(k) number is K182115.

When did Vinyl Patient Examination Gloves receive FDA 510(k) clearance?

Vinyl Patient Examination Gloves received FDA 510(k) clearance on 2018-10-03, under 510(k) number K182115.

Who is the listed applicant for Vinyl Patient Examination Gloves?

The FDA 510(k) record lists Pingan Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vinyl Patient Examination Gloves?

The FDA product code for Vinyl Patient Examination Gloves is LYZ.

列明Pingan Medical Products 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。

K222527丁腈患者检查手套 K210725丁腈患者检查手套

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。