Cleared Traditional

K022095 - DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE

K022095 is an FDA 510(k) clearance for DURACLEAN WITH LYCRA POWDER FREE POLYUR..., manufactured by Wilshire Technologies. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K022095 · Wilshire Technologies · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
43d
Days
Class 1
Risk

K022095 is an FDA 510(k) clearance for the DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wilshire Technologies (San Diego, US). The FDA issued a Cleared decision on August 9, 2002 after a review of 43 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 - K022095

510(k) Number K022095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2002
Decision Date August 09, 2002
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 K022095.
MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
K022347 · Latexx Manufacturing Sdn.Bhd. · Aug 2002
MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
K022548 · Latexx Manufacturing Sdn.Bhd. · Aug 2002
NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)
K021668 · Innovative Gloves Co;, Ltd. · Aug 2002
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
K022101 · Latexx Manufacturing Sdn.Bhd. · Aug 2002
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
K021452 · Maxxim Medical · Aug 2002
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
K022024 · Best Manufacturing Company · Aug 2002
K022095 · DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE
Download PDF FDA Summary Wilshire Technologies