Decision Date2022-10-19
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple is a medical device manufactured by Ever Global (Vietnam) Enterprise Corporation. It received FDA 510(k) clearance on 2022-10-19 under approval number K220992. 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 Powder Free Vinyl Exam Glove, Black/Blue/Purple?
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple is a medical device that received FDA 510(k) clearance on 2022-10-19. It is manufactured by Ever Global (Vietnam) Enterprise Corporation. The 510(k) number is K220992.
When was Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple approved by the FDA?
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple received FDA 510(k) clearance on 2022-10-19, under approval number K220992.
What company makes Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple?
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple is manufactured by Ever Global (Vietnam) Enterprise Corporation.
What is the FDA product code for Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple?
The FDA product code for Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple is LYZ.
Other Devices by Ever Global (Vietnam) Enterprise Corporation
K190403Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
K221980Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
K252244Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid
K244034Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine
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K160411Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera CoatingCardinal Health, Inc.
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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.