Cleared Traditional

POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK (K123328) - FDA 510(k) Clearance

Class I General Hospital device.

K123328 · Nitrilist Gloves Manufacturing Sdn Bhd · General Hospital
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Jan 2013
Decision
88d
Days
Class 1
Risk

K123328 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Nitrilist Gloves Manufacturing Sdn Bhd (Kuala Pilah, MY). The FDA issued a Cleared decision on January 18, 2013 after a review of 88 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 Nitrilist Gloves Manufacturing Sdn Bhd devices

Submission Details

510(k) Number K123328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2012
Decision Date January 18, 2013
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 1169
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K123328.
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