FDA 510(k)

无粉乳胶患者检查手套，透明（无色）

K号: K211865 · 2021-12-20

申请人Liao Ning Shangwei Medical Products Co., Ltd.

决定日期2021-12-20

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

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is the device name listed in this FDA 510(k) record. The listed applicant is Liao Ning Shangwei Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2021-12-20 under 510(k) number K211865. 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 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is Liao Ning Shangwei Medical Products Co., Ltd.. The 510(k) number is K211865.

When did Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) receive FDA 510(k) clearance?

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) received FDA 510(k) clearance on 2021-12-20, under 510(k) number K211865.

Who is the listed applicant for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

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

What is the FDA product code for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

The FDA product code for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is LYZ.

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。

无粉乳胶患者检查手套，透明（无色）

器械摘要

常见问题

相关临床试验

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官方来源