Cleared Traditional

K021961 - POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE

K021961 is an FDA 510(k) clearance for POWDER-FREE POLY-VINYL EXAM GLOVES, manufactured by Copioumed Intl., Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K021961 · Copioumed Intl., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
18d
Days
Class 1
Risk

K021961 is an FDA 510(k) clearance for the POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Copioumed Intl., Inc. (Sparks, US). The FDA issued a Cleared decision on July 2, 2002 after a review of 18 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Copioumed Intl., Inc. devices

FDA 510(k) Submission Details - K021961

510(k) Number K021961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2002
Decision Date July 02, 2002
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 139
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K021961.
VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
K031913 · Arista Latindo Industrial Ltd. P.T · Jul 2003
VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
K023753 · Arista Latindo Industrial Ltd. P.T · Mar 2003
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
K023754 · Arista Latindo Industrial Ltd. P.T · Mar 2003
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K012282 · Cypress Medical Products, Ltd. · Aug 2001
POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
K011186 · Allegiance Healthcare Corp. · May 2001
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · Medline Industries, Inc. · Oct 2000