Cleared Traditional

K123749 - POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE

K123749 is an FDA 510(k) clearance for POWDER FREE NITRILE PATIENT EXAMINATION..., manufactured by Kossan Latex Industries(M)Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K123749 · Kossan Latex Industries(M)Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
85d
Days
Class 1
Risk

K123749 is an FDA 510(k) clearance for the POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Kossan Latex Industries(M)Sdn Bhd (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on March 1, 2013 after a review of 85 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

FDA 510(k) Submission Details - K123749

510(k) Number K123749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2012
Decision Date March 01, 2013
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
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 1012
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K123749.
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K122453 · Industrial Clothings, Ltd. · Apr 2013
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K123869 · Dehai (Shandong) Medical Gloves, Co., Ltd. · Feb 2013
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K122727 · Northstar Healthcare Holdings · Feb 2013
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K130038 · Hl Rubber Industries Sdn Bhd · Feb 2013