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FDA 510(k)

Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple

K-Number: K220992 · 2022-10-19

ApplicantEver Global (Vietnam) Enterprise Corporation
Decision Date2022-10-19
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple is the device name listed in this FDA 510(k) record. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. It received FDA 510(k) clearance on 2022-10-19 under 510(k) 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. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. The 510(k) number is K220992.

When did Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple receive FDA 510(k) clearance?

Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple received FDA 510(k) clearance on 2022-10-19, under 510(k) number K220992.

Who is the listed applicant for Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple?

The FDA 510(k) record lists Ever Global (Vietnam) Enterprise Corporation as the applicant. This does not by itself establish the device manufacturer.

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 records listing Ever Global (Vietnam) Enterprise Corporation as applicant

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.

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 acidK244034Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and XylazineK221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearK193555Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl CitrateK190403Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy DrugsK171422Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color

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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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