Cleared Traditional

K120066 - POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL

K120066 is an FDA 510(k) clearance for POWDER FREE NITRILE PATIENT EXAMINATION..., manufactured by Kossan Latex Industries(M)Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 312-day FDA review.

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

FDA 510(k) Submission Details - K120066

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 129d · This submission: 312d
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 K120066.
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
K121549 · Siam Sempermed Corp., Ltd. · Dec 2012
POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
K122874 · Nitrilist Gloves Manufacturing Sdn Bhd · Dec 2012
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K122999 · Top Glove Sdn. Bhd. · Nov 2012
BLUE POWDERED NITRILE EXAMINATION GLOVE
K122998 · Northstar Healthcare Holdings · Nov 2012
POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
K122131 · Matang Mfg. Sdn. Bhd. · Oct 2012
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
K121992 · Xinwei (Shandong) Plastic and Rubber Products Co., · Oct 2012