Cleared Traditional

K060771 - POWDER-FREE NITRILE PATIENT EXAMINATION...

K060771 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 LZA) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K060771 · Kossan Latex Industries(M)Sdn Bhd · General Hospital
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May 2006
Decision
40d
Days
Class 1
Risk

K060771 is an FDA 510(k) clearance for the POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE CO.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Kossan Latex Industries(M)Sdn Bhd (Klang, Selangor, MY). The FDA issued a Cleared decision on May 1, 2006 after a review of 40 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kossan Latex Industries(M)Sdn Bhd devices

Submission Details

510(k) Number K060771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2006
Decision Date May 01, 2006
Days to Decision 40 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 129d · This submission: 40d
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 584
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K060771.
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
K052583 · Hartalega Sdn Bhd · Jun 2006
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K061192 · Ethicon Endo-Surgery, LLC · May 2006
TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
K060073 · Shen Wei (Usa), Inc. · May 2006
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)
K060753 · Siam Sempermed Corp., Ltd. · Apr 2006
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
K052890 · Siam Sempermed Corp., Ltd. · Oct 2005
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
K051777 · Hartalega Sdn Bhd · Aug 2005