FDA 510(k)

Disposable Synthetic Examination Gloves

K-Number: K210520 · 2021-05-26

ApplicantShandong Shengshixincheng Medical Science & Technology Co.,

Decision Date2021-05-26

Product CodeLYZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Disposable Synthetic Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Shengshixincheng Medical Science & Technology Co.,. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K210520. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Synthetic Examination Gloves?

Disposable Synthetic Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Shandong Shengshixincheng Medical Science & Technology Co.,. The 510(k) number is K210520.

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

Disposable Synthetic Examination Gloves received FDA 510(k) clearance on 2021-05-26, under 510(k) number K210520.

Who is the listed applicant for Disposable Synthetic Examination Gloves?

The FDA 510(k) record lists Shandong Shengshixincheng Medical Science & Technology Co., as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Shandong Shengshixincheng Medical Science & Technology Co., as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210522Disposable Vinyl Examination Gloves

Related Devices (Code: LYZ)

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.