Cleared Traditional

K092874 - POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES

K092874 is an FDA 510(k) clearance for POWDER FREE NITRILE (DARK BLUE) EXAMINA..., manufactured by Quality Gallant Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K092874 · Quality Gallant Sdn. Bhd. · General Hospital
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Jun 2010
Decision
277d
Days
Class 1
Risk

K092874 is an FDA 510(k) clearance for the POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Quality Gallant Sdn. Bhd. (Taiping, Perak, MY). The FDA issued a Cleared decision on June 22, 2010 after a review of 277 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 Quality Gallant Sdn. Bhd. devices

FDA 510(k) Submission Details - K092874

510(k) Number K092874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2009
Decision Date June 22, 2010
Days to Decision 277 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
148d slower than avg
Panel avg: 129d · This submission: 277d
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 790
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K092874.
NUGARD NITILE GREY COLOR
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K093726 · Medline Industries, Inc. · Feb 2010