Cleared Traditional

K123116 - CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)

K123116 is an FDA 510(k) clearance for CHLORINATED POWDER FREE NITRILE EXAMINA..., manufactured by Worldmed Manufacturing Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K123116 · Worldmed Manufacturing Sdn. Bhd. · General Hospital
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Feb 2013
Decision
131d
Days
Class 1
Risk

K123116 is an FDA 510(k) clearance for the CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Worldmed Manufacturing Sdn. Bhd. (Kamunting, MY). The FDA issued a Cleared decision on February 11, 2013 after a review of 131 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 Worldmed Manufacturing Sdn. Bhd. devices

FDA 510(k) Submission Details - K123116

510(k) Number K123116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2012
Decision Date February 11, 2013
Days to Decision 131 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
2d slower than avg
Panel avg: 129d · This submission: 131d
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 753
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K123116.
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
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
K123749 · Kossan Latex Industries(M)Sdn Bhd · Mar 2013
POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
K122696 · Cardinal Health, Inc. · Jan 2013
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
K121549 · Siam Sempermed Corp., Ltd. · Dec 2012
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K122999 · Top Glove Sdn. Bhd. · Nov 2012