Cleared Traditional

K092160 - POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES

K092160 is an FDA 510(k) clearance for POWDERFREE NITRILE (DARK BLUE) EXAMINAT..., manufactured by Comfort Rubber Gloves Ind. Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K092160 · Comfort Rubber Gloves Ind. Sdn. Bhd. · General Hospital
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Nov 2009
Decision
134d
Days
Class 1
Risk

K092160 is an FDA 510(k) clearance for the POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Comfort Rubber Gloves Ind. Sdn. Bhd. (Taiping, Perak, MY). The FDA issued a Cleared decision on November 27, 2009 after a review of 134 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K092160

510(k) Number K092160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2009
Decision Date November 27, 2009
Days to Decision 134 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
5d slower than avg
Panel avg: 129d · This submission: 134d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K092160.
MULTIPLE NAME MODEL MULTIPLE
K093759 · Gx Corporation Sdn Bhd (Plant 1) · Feb 2010
SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803
K093696 · Central Medicare Sdn Bhd · Feb 2010
STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K091851 · Gx Corporation Sdn Bhd · Dec 2009
POWDER FREE NITRILE EXAMINATION GLOVES BLACK
K091965 · Platinum Glove Industries Sdn. Bhd. · Nov 2009
LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
K092498 · La Glove (M) Sdn. Bhd. · Nov 2009
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
K092072 · Gx Corporation Sdn Bhd · Nov 2009
K092160 · POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES
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