Cleared Traditional

K221980 - Disposable Powder Free Vinyl Examinatio...

K221980 is an FDA 510(k) clearance for Disposable Powder Free Vinyl Examinatio..., manufactured by Ever Global (Vietnam) Enterprise Corporation. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K221980 · Ever Global (Vietnam) Enterprise Corporation · General Hospital
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Feb 2023
Decision
216d
Days
Class 1
Risk

K221980 is an FDA 510(k) clearance for the Disposable Powder Free Vinyl Examination Gloves, Beige/Clear. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Ever Global (Vietnam) Enterprise Corporation (Taman Village, VN). The FDA issued a Cleared decision on February 6, 2023 after a review of 216 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ever Global (Vietnam) Enterprise Corporation devices

FDA 510(k) Submission Details - K221980

510(k) Number K221980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 129d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LYZ Vinyl Patient Examination Glove

All 99
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K221980.
Powder-Free Vinyl Exam Gloves, clear
K252505 · Basic Medical Technology, Inc. · Aug 2025
Disposable Vinyl Examination Gloves
K241252 · Anqing Pukang Medical Technology Co., Ltd. · May 2024
Vinyl examination gloves
K230046 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Mar 2023
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
K220992 · Ever Global (Vietnam) Enterprise Corporation · Oct 2022
Disposable Vinyl Examination Gloves
K223008 · Jiangxi Handspro Products Solutions Co., Ltd. · Oct 2022
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
K222442 · Anhui Bytech Medical Supplies Co., Ltd. · Sep 2022