Cleared Traditional

K080066 - VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR) (FDA 510(k) Clearance)

Class I General Hospital device.

K080066 · Gx Corporation Sdn Bhd · General Hospital
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Mar 2008
Decision
55d
Days
Class 1
Risk

K080066 is an FDA 510(k) clearance for the VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Gx Corporation Sdn Bhd (Klang, Selangor, MY). The FDA issued a Cleared decision on March 5, 2008 after a review of 55 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 Gx Corporation Sdn Bhd devices

Submission Details

510(k) Number K080066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2008
Decision Date March 05, 2008
Days to Decision 55 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 128d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 1167
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K080066.
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K251716 · Basic Medical Technology, Inc. · Aug 2025