Cleared Traditional

K080536 - MICRO-TOUCH NITRAFREE

K080536 is an FDA 510(k) clearance for MICRO-TOUCH NITRAFREE, manufactured by Ansell Healthcare Products, LLC. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K080536 · Ansell Healthcare Products, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2008
Decision
113d
Days
Class 1
Risk

K080536 is an FDA 510(k) clearance for the MICRO-TOUCH NITRAFREE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ansell Healthcare Products, LLC (Dothan, US). The FDA issued a Cleared decision on June 19, 2008 after a review of 113 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 Ansell Healthcare Products, LLC devices

FDA 510(k) Submission Details - K080536

510(k) Number K080536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2008
Decision Date June 19, 2008
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
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 1012
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K080536.
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
POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
K080937 · Gx Corporation Sdn Bhd · May 2008
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
K080520 · Siam Sempermed Corp., Ltd. · Apr 2008
NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
K072400 · Sgmp Co., Ltd. · Mar 2008