FDA 510(k)

一次性乙烯基检查手套

K号: K211236 · 2021-09-27

申请人Tangshan Hongyun Healthcare Products Co., Ltd.

决定日期2021-09-27

产品代码LYZ

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 Vinyl Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Tangshan Hongyun Healthcare Products Co., Ltd.. It received FDA 510(k) clearance on 2021-09-27 under 510(k) number K211236. 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 Disposable Vinyl Examination Gloves?

Disposable Vinyl Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-09-27. The listed applicant is Tangshan Hongyun Healthcare Products Co., Ltd.. The 510(k) number is K211236.

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

Disposable Vinyl Examination Gloves received FDA 510(k) clearance on 2021-09-27, under 510(k) number K211236.

Who is the listed applicant for Disposable Vinyl Examination Gloves?

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

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

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

列明Tangshan Hongyun Healthcare 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。

K211262一次性乙烯基丁腈合成手套无粉

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。