Cleared Traditional

K121529 - BLACK NITRILE POWDER-FREE EXAMINATION G...

K121529 is an FDA 510(k) clearance for BLACK NITRILE POWDER-FREE EXAMINATION G..., manufactured by Northstar Healthcare Holdings. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K121529 · Northstar Healthcare Holdings · General Hospital
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Jul 2012
Decision
49d
Days
Class 1
Risk

K121529 is an FDA 510(k) clearance for the BLACK NITRILE POWDER-FREE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Northstar Healthcare Holdings (Hamilton, Bermuda, IE). The FDA issued a Cleared decision on July 12, 2012 after a review of 49 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 Northstar Healthcare Holdings devices

FDA 510(k) Submission Details - K121529

510(k) Number K121529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2012
Decision Date July 12, 2012
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 702
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K121529.
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K121528 · Shen Wei (Usa), Inc. · Sep 2012
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K122363 · Siam Sempermed Corp., Ltd. · Sep 2012
POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
K120890 · Shen Wei (Usa), Inc. · Aug 2012
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
K113423 · Kimberly-Clark Corp. · Mar 2012
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
K111248 · Yty Industry (Manjung) Sdn Bhd · Dec 2011
NITRILE POWDER FREE EXAMINATION GLOVES
K110758 · Hartalega Sdn Bhd · Aug 2011