Cleared Special

K023153 - MICRO-TOUCH NEXT STEP POWDER FREE MEDIC...

K023153 is an FDA 510(k) clearance for MICRO-TOUCH NEXT STEP POWDER FREE MEDIC..., manufactured by Ansell Healthcare Products, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Special 510(k) pathway after a 51-day FDA review.

K023153 · Ansell Healthcare Products, Inc. · General Hospital
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Nov 2002
Decision
51d
Days
Class 1
Risk

K023153 is an FDA 510(k) clearance for the MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GL.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Ansell Healthcare Products, Inc. (Massillon, US). The FDA issued a Cleared decision on November 13, 2002 after a review of 51 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ansell Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K023153

510(k) Number K023153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2002
Decision Date November 13, 2002
Days to Decision 51 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 293
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K023153.
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM
K024121 · Siam Sempermed Corp., Ltd. · Dec 2002
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K024102 · Allegiance Healthcare Corp. · Dec 2002
POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G)
K023577 · Yty Industry (Manjung) Sdn Bhd · Dec 2002
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
K023590 · Yty Industry (Manjung) Sdn Bhd · Nov 2002
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)
K023262 · Perusahaan Getah Asas Sdn. Bhd. · Oct 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
K022220 · Shen Wei (Usa), Inc. · Sep 2002