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FDA 510(k)

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

K-Number: K191292 · 2019-11-05

ApplicantAnhui Powerguard Technology Co., Ltd.
Decision Date2019-11-05
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a medical device manufactured by Anhui Powerguard Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-11-05 under approval number K191292. 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 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 2019-11-05. It is manufactured by Anhui Powerguard Technology Co., Ltd.. The 510(k) number is K191292.

When was Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) approved by the FDA?

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) received FDA 510(k) clearance on 2019-11-05, under approval number K191292.

What company makes Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)?

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is manufactured by Anhui Powerguard Technology Co., Ltd..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026)

Other Devices by Anhui Powerguard Technology Co., Ltd.

K211860Powder Free Nitrile Patient Examination Gloves, Blue Color K233520Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl

Related Devices (Code: LYZ)

K162259DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)Zibo Daiyang Plastic Company K161390Vinyl Exam Gloves, Powder Free, ClearZibo Hongchin Plastic and Rubber Co., Ltd. K160675Powder free vinyl patient examination glove, colored (yellow)Kaixing Plastic Products Co., Litd. K160411Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera CoatingCardinal Health, Inc. K161072Powder Free Grey Vinyl Examination GlovesZibo Flourish Trading Co., Ltd. K160468Synthetic Vinyl Examination Gloves, Powder-Free, YellowInpro Technology Device Factory

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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