Cleared Traditional

K071910 - NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)

K071910 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 57-day FDA review.

K071910 · Hartalega Sdn Bhd · General Hospital
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Sep 2007
Decision
57d
Days
Class 1
Risk

K071910 is an FDA 510(k) clearance for the NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATIO.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Selangor, Darul Ehsan, MY). The FDA issued a Cleared decision on September 6, 2007 after a review of 57 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.

FDA 510(k) Submission Details - K071910

510(k) Number K071910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2007
Decision Date September 06, 2007
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 1180
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K071910.
VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK, AND GRAY COLOR)
K080066 · Gx Corporation Sdn Bhd · Mar 2008
CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES
K071740 · Medtexx Manufacturing Sdn. Bhd. · Oct 2007
POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
K071170 · Smart Glove Corp. Sdn Bhd · Sep 2007
SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
K071072 · Shanghai China Star Corp · Aug 2007
MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES
K071207 · High Momentum Sdn Bhd · Aug 2007
MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES
K071208 · High Momentum Sdn Bhd · Jul 2007
K071910 · NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK)
Download PDF Hartalega Sdn Bhd