Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Powder Free Vinyl Examination Gloves, Beige/Clear

K-Number: K221980 · 2023-02-06

ApplicantEver Global (Vietnam) Enterprise Corporation
Decision Date2023-02-06
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Powder Free Vinyl Examination Gloves, Beige/Clear 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 2023-02-06 under 510(k) 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. The listed applicant is Ever Global (Vietnam) Enterprise Corporation. The 510(k) number is K221980.

When did Disposable Powder Free Vinyl Examination Gloves, Beige/Clear receive FDA 510(k) clearance?

Disposable Powder Free Vinyl Examination Gloves, Beige/Clear received FDA 510(k) clearance on 2023-02-06, under 510(k) number K221980.

Who is the listed applicant for Disposable Powder Free Vinyl Examination Gloves, Beige/Clear?

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 Examination Gloves, Beige/Clear?

The FDA product code for Disposable Powder Free Vinyl Examination Gloves, Beige/Clear 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 XylazineK220992Disposable Powder Free Vinyl Exam Glove, Black/Blue/PurpleK193555Disposable 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

View all 8 devices →

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.K220992Disposable Powder Free Vinyl Exam Glove, Black/Blue/PurpleEver 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.

↑