Cleared Traditional

K090412 - POWDER FREE NITRILE EXAMINATION GLOVES ...

K090412 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVES ..., manufactured by Gx Corporation Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K090412 · Gx Corporation Sdn Bhd · General Hospital
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Jun 2009
Decision
103d
Days
Class 1
Risk

K090412 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES (PINK, GREEN, ORANGE,WHITE).. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Gx Corporation Sdn Bhd (Klang, Selangor, MY). The FDA issued a Cleared decision on June 1, 2009 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Gx Corporation Sdn Bhd devices

FDA 510(k) Submission Details - K090412

510(k) Number K090412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2009
Decision Date June 01, 2009
Days to Decision 103 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
26d faster than avg
Panel avg: 129d · This submission: 103d
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 685
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K090412.
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
K091652 · Hartalega Sdn Bhd · Sep 2009
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K091147 · Smart Glove Corp. Sdn Bhd · Jul 2009
POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
K090194 · Shen Wei (Usa), Inc. · Jul 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS
K082957 · Siam Sempermed Corp., Ltd. · May 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
K083755 · Siam Sempermed Corp., Ltd. · Mar 2009
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
K081911 · Siam Sempermed Corp., Ltd. · Jan 2009