Cleared Traditional

K023979 - NITRILE EXAMINATION GLOVES, PRE-POWDERED

K023979 is an FDA 510(k) clearance for NITRILE EXAMINATION GLOVES, manufactured by Starmatrix Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K023979 · Starmatrix Sdn Bhd · General Hospital
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Jan 2003
Decision
53d
Days
Class 1
Risk

K023979 is an FDA 510(k) clearance for the NITRILE EXAMINATION GLOVES, PRE-POWDERED. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Starmatrix Sdn Bhd (Petaling Jaya, Selangor, MY). The FDA issued a Cleared decision on January 24, 2003 after a review of 53 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 - K023979

510(k) Number K023979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2002
Decision Date January 24, 2003
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 1181
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K023979.
MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED)
K022814 · Pt. Smartglove Indonesia · Feb 2003
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR
K023072 · Arista Latindo Industrial Ltd. P.T · Feb 2003
NITRILE EXAMINATION GLOVES, POWDER FREE
K023978 · Starmatrix Sdn Bhd · Jan 2003
POWDER-FREE COATED NITRILE EXAMINATION GLOVE, BLUE COLORED
K024184 · Perusahaan Getah Asas Sdn. Bhd. · Jan 2003
GREEN POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
K024083 · Supermax Glove Manufacturing Sdn Bhd · Jan 2003
POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE
K023702 · Ningbo Tianshun Rubber Products Co., Ltd. · Dec 2002
K023979 · NITRILE EXAMINATION GLOVES, PRE-POWDERED
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