Decision Date2023-02-06
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear is a medical device manufactured by Ever Global (Vietnam) Enterprise Corporation. It received FDA 510(k) clearance on 2023-02-06 under approval number K221980. 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 Examination Gloves, Beige/Clear?
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear is a medical device that received FDA 510(k) clearance on 2023-02-06. It is manufactured by Ever Global (Vietnam) Enterprise Corporation. The 510(k) number is K221980.
When was Disposable Powder Free Vinyl Examination Gloves, Beige/Clear approved by the FDA?
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear received FDA 510(k) clearance on 2023-02-06, under approval number K221980.
What company makes Disposable Powder Free Vinyl Examination Gloves, Beige/Clear?
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear is manufactured by Ever Global (Vietnam) Enterprise Corporation.
What is the FDA product code for Disposable Powder Free Vinyl Examination Gloves, Beige/Clear?
The FDA product code for Disposable Powder Free Vinyl Examination Gloves, Beige/Clear 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
K220992Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
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
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.