Cleared Traditional

K110960 - ROYAL IMPERIAL NITRILE EXAMINATION GLOV...

K110960 is an FDA 510(k) clearance for ROYAL IMPERIAL NITRILE EXAMINATION GLOV..., manufactured by Koon Seng Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K110960 · Koon Seng Sdn Bhd · General Hospital
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Jul 2011
Decision
100d
Days
Class 1
Risk

K110960 is an FDA 510(k) clearance for the ROYAL IMPERIAL NITRILE EXAMINATION GLOVES TEXTURED POWDER-FREE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Koon Seng Sdn Bhd (Greenwood Village, US). The FDA issued a Cleared decision on July 14, 2011 after a review of 100 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 Koon Seng Sdn Bhd devices

FDA 510(k) Submission Details - K110960

510(k) Number K110960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2011
Decision Date July 14, 2011
Days to Decision 100 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 129d · This submission: 100d
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 683
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K110960.
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K101820 · Yty Industry (Manjung) Sdn Bhd · Mar 2011
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K103249 · Cardinal Health, Inc. · Dec 2010