Cleared Traditional

K061192 - BLUE COLOUR POWDER FREE BARRIERPRO POLY...

K061192 is the FDA 510(k) clearance for BLUE COLOUR POWDER FREE BARRIERPRO POLY... by Ethicon Endo-Surgery, LLC. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K061192 · Ethicon Endo-Surgery, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
25d
Days
Class 1
Risk

K061192 is an FDA 510(k) clearance for the BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER EXA.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on May 23, 2006 after a review of 25 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 Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K061192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2006
Decision Date May 23, 2006
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
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 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K061192.
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
K063046 · Hartalega Sdn Bhd · Nov 2006
TEXTURED POWER FREE BP2000 (BUTADIENE POLYMER) EXAM GLOVES, NATURAL COLOR
K062067 · Shen Wei (Usa), Inc. · Sep 2006
BLUE POWDER FREE NITRILE EXAMINATION GLOVES
K052583 · Hartalega Sdn Bhd · Jun 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