Cleared Traditional

K122131 - POWDER FREE NITRILE EXAMINATION GLOVE-B...

K122131 is the FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVE-B... by Matang Mfg. Sdn. Bhd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K122131 · Matang Mfg. Sdn. Bhd. · General Hospital
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Oct 2012
Decision
91d
Days
Class 1
Risk

K122131 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Matang Mfg. Sdn. Bhd. (Jasin, Melaka, MY). The FDA issued a Cleared decision on October 17, 2012 after a review of 91 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 Matang Mfg. Sdn. Bhd. devices

Submission Details

510(k) Number K122131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2012
Decision Date October 17, 2012
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 584
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K122131.
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU)
K132006 · Hartalega Sdn Bhd · Nov 2013
NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
K130473 · Hartalega Sdn Bhd · Jul 2013
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
K121549 · Siam Sempermed Corp., Ltd. · Dec 2012
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