Cleared Traditional

K063046 - NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)

K063046 is an FDA 510(k) clearance for NITRILE POWDER FREE EXAMINATION GLOVES ..., manufactured by Hartalega Sdn Bhd. The device is a Class 1 General Hospital device with 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

FDA 510(k) Submission Details - K063046

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.

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 907
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K063046.
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
K062919 · Shen Wei (Usa), Inc. · Mar 2007
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
K063627 · Smart Glove Corp. Sdn Bhd · Mar 2007
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, WHITE, PINK, BLACK AND GRAY COLOR
K070096 · Gx Corporation Sdn Bhd · Mar 2007
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
K062067 · Shen Wei (Usa), Inc. · Sep 2006
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
K061724 · Smart Glove Corp. Sdn Bhd · Jul 2006
NON-STERILE, POWDER-FREE BLACK NITRILE EXAMINATION GLOVES
K061553 · Yty Industry (Manjung) Sdn Bhd · Jul 2006