Cleared Traditional

K013303 - CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER

K013303 is an FDA 510(k) clearance for CLEANTEXX POWDERFREE SYNTHETIC LATEX EX..., manufactured by Latexx 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 111-day FDA review.

K013303 · Latexx Manufacturing Sdn.Bhd. · General Hospital
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Jan 2002
Decision
111d
Days
Class 1
Risk

K013303 is an FDA 510(k) clearance for the CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Latexx Manufacturing Sdn.Bhd. (Taiping, Perak, MY). The FDA issued a Cleared decision on January 23, 2002 after a review of 111 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 Latexx Manufacturing Sdn.Bhd. devices

FDA 510(k) Submission Details - K013303

510(k) Number K013303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2001
Decision Date January 23, 2002
Days to Decision 111 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 129d · This submission: 111d
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 762
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K013303.
SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE
K020751 · Syntex Healthcare Products Co., Ltd. · May 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE
K020493 · Syntex Healthcare Products Co., Ltd. · Feb 2002
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE
K020317 · Sgmp Co., Ltd. · Feb 2002
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · Smart Glove Corp. Sdn Bhd · Nov 2001
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016 · Tillotson Healthcare Corp. · Oct 2001
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961 · Shen Wei (Usa), Inc. · Sep 2001