Cleared Traditional

K092200 - POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)

K092200 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVES, manufactured by Gx Corporation Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K092200 · Gx Corporation Sdn Bhd · General Hospital
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Sep 2009
Decision
56d
Days
Class 1
Risk

K092200 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANIL.... 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 September 16, 2009 after a review of 56 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

FDA 510(k) Submission Details - K092200

510(k) Number K092200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2009
Decision Date September 16, 2009
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

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 1160
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K092200.
POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
K092034 · Pt. Smartglove Indonesia · Oct 2009
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
K090568 · Medline Industries, Inc. · Oct 2009
MICRO-TOUCH NITRA FREE
K092327 · Ansell Healthcare Products, LLC · Sep 2009
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
K091652 · Hartalega Sdn Bhd · Sep 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES
K090828 · Ultrawin Sdn Bhd · Jul 2009
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K091147 · Smart Glove Corp. Sdn Bhd · Jul 2009