Cleared Traditional

K080937 - POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE (FDA 510(k) Clearance)

Class I General Hospital device.

K080937 · Gx Corporation Sdn Bhd · General Hospital
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May 2008
Decision
51d
Days
Class 1
Risk

K080937 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Gx Corporation Sdn Bhd (Klang, Selang Darul Ehsan, MY). The FDA issued a Cleared decision on May 23, 2008 after a review of 51 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 K080937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2008
Decision Date May 23, 2008
Days to Decision 51 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
77d faster than avg
Panel avg: 128d · This submission: 51d
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
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