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.

View all Comfort Rubber Gloves Ind. Sdn. Bhd. devices

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 799
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K092160.
MICRO-TOUCH NITRILE
K093523 · Ansell Healthcare Products, LLC · Mar 2010
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STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K091851 · Gx Corporation Sdn Bhd · Dec 2009
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K092498 · La Glove (M) Sdn. Bhd. · Nov 2009
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
K092072 · Gx Corporation Sdn Bhd · Nov 2009
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
K092411 · Shen Wei (Usa), Inc. · Oct 2009