Cleared Traditional

K040176 - MAXTER POWDER FREE NITRILE MEDICAL EXAM...

K040176 is an FDA 510(k) clearance for MAXTER POWDER FREE NITRILE MEDICAL EXAM..., manufactured by Maxter Glove 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 29-day FDA review.

K040176 · Maxter Glove Manufacturing Sdn Bhd · General Hospital
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Feb 2004
Decision
29d
Days
Class 1
Risk

K040176 is an FDA 510(k) clearance for the MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Maxter Glove Manufacturing Sdn Bhd (Meru, Klang, MY). The FDA issued a Cleared decision on February 24, 2004 after a review of 29 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 Maxter Glove Manufacturing Sdn Bhd devices

FDA 510(k) Submission Details - K040176

510(k) Number K040176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2004
Decision Date February 24, 2004
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
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 725
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K040176.
MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
K040607 · Pt. Medisafe Technologies · Apr 2004
NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K033887 · Yty Industry (Manjung) Sdn Bhd · Mar 2004
NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE
K033086 · Pt. Medisafe Technologies · Feb 2004
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
K033683 · Smart Glove Corp. Sdn Bhd · Jan 2004
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K032024 · Shen Wei (Usa), Inc. · Oct 2003
VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
K031944 · Arista Latindo Industrial Ltd. P.T · Sep 2003