Cleared Traditional

POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL (K120066) - FDA 510(k) Clearance

Class I General Hospital device.

K120066 · Kossan Latex Industries(M)Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
312d
Days
Class 1
Risk

K120066 is an FDA 510(k) clearance for the POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED..... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Kossan Latex Industries(M)Sdn Bhd (Klang, Selangor D.E., MY). The FDA issued a Cleared decision on November 16, 2012 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K120066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2012
Decision Date November 16, 2012
Days to Decision 312 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
183d slower than avg
Panel avg: 129d · This submission: 312d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 1169
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K120066.
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