Cleared Traditional

K121192 - NITRILE EXAMINATION GLOVES (WHITE

K121192 is the FDA 510(k) clearance for NITRILE EXAMINATION GLOVES (WHITE by Tekmedic (M) Sdn Bhd. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K121192 · Tekmedic (M) Sdn Bhd · General Hospital
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Aug 2012
Decision
106d
Days
Class 1
Risk

K121192 is an FDA 510(k) clearance for the NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Tekmedic (M) Sdn Bhd (Tanjung Bruas Jetty, Tanjung Kling, MY). The FDA issued a Cleared decision on August 3, 2012 after a review of 106 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 Tekmedic (M) Sdn Bhd devices

Submission Details

510(k) Number K121192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2012
Decision Date August 03, 2012
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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 555
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K121192.
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
K130473 · Hartalega Sdn Bhd · Jul 2013
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K121528 · Shen Wei (Usa), Inc. · 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
NITRILE POWDER FREE EXAMINATION GLOVES
K110758 · Hartalega Sdn Bhd · Aug 2011
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
K102032 · Kimberly-Clark Corp. · Sep 2010