Cleared Traditional

Disposable Powder Free Vinyl Examination Gloves, Beige/Clear

K221980 · Ever Global (Vietnam) Enterprise Corporation · General Hospital

Feb 2023

Decision

216d

Days

Class 1

Risk

About This 510(k) Submission

K221980 is an FDA 510(k) clearance for the Disposable Powder Free Vinyl Examination Gloves, Beige/Clear, a Vinyl Patient Examination Glove (Class I — General Controls, product code LYZ), submitted by Ever Global (Vietnam) Enterprise Corporation (Taman Village, VN). The FDA issued a Cleared decision on February 6, 2023, 216 days after receiving the submission on July 5, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K221980 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2022
Decision Date	February 06, 2023
Days to Decision	216 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	LYZ — Vinyl Patient Examination Glove
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.