Cleared Traditional

K133956 - NITRILE POWDER FREE EXAMINATION GLOVE W...

K133956 is the FDA 510(k) clearance for NITRILE POWDER FREE EXAMINATION GLOVE W... by Hartalega Sdn Bhd. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K133956 · Hartalega Sdn Bhd · General Hospital
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May 2014
Decision
156d
Days
Class 1
Risk

K133956 is an FDA 510(k) clearance for the NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECT.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Bestari Jaya, MY). The FDA issued a Cleared decision on May 28, 2014 after a review of 156 days - an extended review 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: 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 Hartalega Sdn Bhd devices

Submission Details

510(k) Number K133956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date May 28, 2014
Days to Decision 156 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 129d · This submission: 156d
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 554
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K133956.
Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
K150103 · Hartalega Sdn Bhd · Apr 2015
Nitrile Powder Free Examination Glove (Blue)
K142588 · Hartalega Sdn Bhd · Dec 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
K140050 · Hartalega Sdn Bhd · Sep 2014
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
K131841 · Kimberly-Clark Corp. · Nov 2013
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