Cleared Traditional

K022346 - CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES

K022346 is an FDA 510(k) clearance for CLEANTEXX MINT FLAVOUR BLUE COLOUR POWD..., 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 91-day FDA review.

K022346 · Latexx Manufacturing Sdn.Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
91d
Days
Class 1
Risk

K022346 is an FDA 510(k) clearance for the CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINAT.... 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 October 18, 2002 after a review of 91 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.

FDA 510(k) Submission Details - K022346

510(k) Number K022346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2002
Decision Date October 18, 2002
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K022346.
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
K022784 · Syntex Healthcare Products Co., Ltd. · Nov 2002
NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES
K022572 · Ar Alliance Healthcare Sdn. Bhd. · Nov 2002
VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE
K023428 · Shanghai Jiawang Industrial Co. , Ltd. · Oct 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K022765 · Allegiance Healthcare Corp. · Oct 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170 · Allegiance Healthcare Corp. · Oct 2002
MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE
K022781 · Industrial Clothings, Ltd. · Oct 2002
K022346 · CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
Download PDF FDA Summary Latexx Manufacturing …