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FDA 510(k)

Synthetic Vinyl Examination Gloves, Powder-Free, Yellow

K-Number: K160468 · 2016-06-23

ApplicantInpro Technology Device Factory
Decision Date2016-06-23
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Synthetic Vinyl Examination Gloves, Powder-Free, Yellow is the device name listed in this FDA 510(k) record. The listed applicant is Inpro Technology Device Factory. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K160468. 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 Synthetic Vinyl Examination Gloves, Powder-Free, Yellow?

Synthetic Vinyl Examination Gloves, Powder-Free, Yellow is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Inpro Technology Device Factory. The 510(k) number is K160468.

When did Synthetic Vinyl Examination Gloves, Powder-Free, Yellow receive FDA 510(k) clearance?

Synthetic Vinyl Examination Gloves, Powder-Free, Yellow received FDA 510(k) clearance on 2016-06-23, under 510(k) number K160468.

Who is the listed applicant for Synthetic Vinyl Examination Gloves, Powder-Free, Yellow?

The FDA 510(k) record lists Inpro Technology Device Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synthetic Vinyl Examination Gloves, Powder-Free, Yellow?

The FDA product code for Synthetic Vinyl Examination Gloves, Powder-Free, Yellow 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

View on FDA Database →

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

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