Cleared Traditional

K081315 - POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT)

K081315 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 94-day FDA review.

K081315 · Gx Corporation Sdn Bhd · General Hospital
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Aug 2008
Decision
94d
Days
Class 1
Risk

K081315 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS.... 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 August 11, 2008 after a review of 94 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 - K081315

510(k) Number K081315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2008
Decision Date August 11, 2008
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
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 1162
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K081315.
MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
K081594 · Medline Industries, Inc. · Oct 2008
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K082370 · Smart Glove Corp. Sdn Bhd · Oct 2008
DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS
K081569 · Dynarex Corporation · Sep 2008
STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K081466 · Smart Glove Corp. Sdn Bhd · Jul 2008
KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
K081260 · Kimberly-Clark Corp. · Jul 2008
KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
K081027 · Kimberly-Clark Corp. · Jun 2008