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FDA 510(k)

Powder-free Clear Vinyl Patient Examination Gloves

K-Number: K171460 · 2017-09-24

ApplicantShandong Zhiwei Medical Products, Co. , Ltd.
Decision Date2017-09-24
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder-free Clear Vinyl Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Zhiwei Medical Products, Co. , Ltd.. It received FDA 510(k) clearance on 2017-09-24 under 510(k) number K171460. 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 Powder-free Clear Vinyl Patient Examination Gloves?

Powder-free Clear Vinyl Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2017-09-24. The listed applicant is Shandong Zhiwei Medical Products, Co. , Ltd.. The 510(k) number is K171460.

When did Powder-free Clear Vinyl Patient Examination Gloves receive FDA 510(k) clearance?

Powder-free Clear Vinyl Patient Examination Gloves received FDA 510(k) clearance on 2017-09-24, under 510(k) number K171460.

Who is the listed applicant for Powder-free Clear Vinyl Patient Examination Gloves?

The FDA 510(k) record lists Shandong Zhiwei 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 Clear Vinyl Patient Examination Gloves?

The FDA product code for Powder-free Clear Vinyl Patient Examination Gloves is LYZ.

Related Devices (Code: LYZ)

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.

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.

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