Cleared Traditional

K062764 - POWDER-FREE NITRILE PATIENT EXAMINATION...

K062764 is the FDA 510(k) clearance for POWDER-FREE NITRILE PATIENT EXAMINATION... by Kossan Latex Industries(M)Sdn Bhd. It is a Class 1 General Hospital device (product code LZC) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K062764 · Kossan Latex Industries(M)Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
165d
Days
Class 1
Risk

K062764 is an FDA 510(k) clearance for the POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE C.... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Kossan Latex Industries(M)Sdn Bhd (Klang, Selangor D.E., MY). The FDA issued a Cleared decision on February 27, 2007 after a review of 165 days - an extended review 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: 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 Kossan Latex Industries(M)Sdn Bhd devices

Submission Details

510(k) Number K062764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2006
Decision Date February 27, 2007
Days to Decision 165 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
36d slower than avg
Panel avg: 129d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 - LZC Medical Glove, Specialty

All 41
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K062764.
POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL
K083409 · Wrp Asia Pacific Sdn. Bhd. · Jul 2009
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
K083305 · Wrp Asia Pacific Sdn. Bhd. · Jun 2009
KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
K081089 · Kimberly-Clark Corp. · Jul 2008
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · Allegiance Healthcare Corp. · Feb 2001
FLUORO-SHIELD RADIATION REDUCTION GLOVES
K920620 · Acufex Microsurgical, Inc. · Jun 1993
FLOUROSHIELD RADIATION REDUCTION GLOVE
K893093 · Acufex Microsurgical, Inc. · Feb 1990