Cleared Traditional

K992496 - POWDER-FREE NITRILE EXAMINATION GLOVE

K992496 is the FDA 510(k) clearance for POWDER-FREE NITRILE EXAMINATION GLOVE by Kossan Latex Industries(M)Sdn Bhd. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K992496 · Kossan Latex Industries(M)Sdn Bhd · General Hospital
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Aug 1999
Decision
30d
Days
Class 1
Risk

K992496 is an FDA 510(k) clearance for the POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Kossan Latex Industries(M)Sdn Bhd (Klang, Selangor, MY). The FDA issued a Cleared decision on August 25, 1999 after a review of 30 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 Kossan Latex Industries(M)Sdn Bhd devices

Submission Details

510(k) Number K992496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date August 25, 1999
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
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 584
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K992496.
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K993876 · Shen Wei (Usa), Inc. · Feb 2000
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
K993313 · Wrp Asia Pacific Sdn. Bhd. · Nov 1999
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
K993311 · Wrp Asia Pacific Sdn. Bhd. · Nov 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K990283 · Hartalega Sdn Bhd · Mar 1999
POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
K972090 · Shen Wei (Usa), Inc. · Nov 1997
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
K963804 · Hartalega Sdn Bhd · Feb 1997