FDA 510(k)

一次性乙烯基丁腈合成手套无粉

K号: K211516 · 2021-08-24

申请人Tangshan Hongyun Plastic Products Co., Ltd.

决定日期2021-08-24

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 Nitrile Synthetic Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Tangshan Hongyun Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2021-08-24 under 510(k) number K211516. 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 Nitrile Synthetic Gloves Powder Free?

Disposable Vinyl Nitrile Synthetic Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2021-08-24. The listed applicant is Tangshan Hongyun Plastic Products Co., Ltd.. The 510(k) number is K211516.

When did Disposable Vinyl Nitrile Synthetic Gloves Powder Free receive FDA 510(k) clearance?

Disposable Vinyl Nitrile Synthetic Gloves Powder Free received FDA 510(k) clearance on 2021-08-24, under 510(k) number K211516.

Who is the listed applicant for Disposable Vinyl Nitrile Synthetic Gloves Powder Free?

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

What is the FDA product code for Disposable Vinyl Nitrile Synthetic Gloves Powder Free?

The FDA product code for Disposable Vinyl Nitrile Synthetic Gloves Powder Free is LYZ.

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一次性乙烯基丁腈合成手套无粉

器械摘要

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