Cleared Traditional

K063046 - NITRILE POWDER FREE EXAMINATION GLOVES ...

K063046 is the FDA 510(k) clearance for NITRILE POWDER FREE EXAMINATION GLOVES ... by Hartalega Sdn Bhd. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K063046 · Hartalega Sdn Bhd · General Hospital
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Nov 2006
Decision
44d
Days
Class 1
Risk

K063046 is an FDA 510(k) clearance for the NITRILE POWDER FREE EXAMINATION GLOVES (GREEN). 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 November 17, 2006 after a review of 44 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 Hartalega Sdn Bhd devices

Submission Details

510(k) Number K063046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2006
Decision Date November 17, 2006
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
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 K063046.
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
K071910 · Hartalega Sdn Bhd · Sep 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP
K061756 · Shen Wei (Usa), Inc. · Apr 2007
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
K062919 · Shen Wei (Usa), Inc. · Mar 2007
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
K062067 · Shen Wei (Usa), Inc. · Sep 2006
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
K052583 · Hartalega Sdn Bhd · Jun 2006
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K061192 · Ethicon Endo-Surgery, LLC · May 2006