Cleared Traditional

K120184 - POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED

K120184 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVE, manufactured by Encompass Medical Supplies Inc Limited. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K120184 · Encompass Medical Supplies Inc Limited · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
100d
Days
Class 1
Risk

K120184 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Encompass Medical Supplies Inc Limited (Shanghai, CN). The FDA issued a Cleared decision on May 2, 2012 after a review of 100 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K120184

510(k) Number K120184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2012
Decision Date May 02, 2012
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K120184.
HIGH FIVE
K113440 · Central Medicare Sdn Bhd · May 2012
C2 MEDICAL GLOVES
K113639 · Amercare, Inc. · May 2012
RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME
K112924 · Riverstone Resources Sdn Bhd · May 2012
PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
K111464 · Dipped Products (Thailand), Ltd. · Apr 2012
RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME
K112928 · Riverstone Resources Sdn Bhd · Apr 2012
NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES
K112012 · Ug Healthcare (Usa), Inc. · Mar 2012
K120184 · POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED
Download PDF FDA Summary Encompass Medical Sup…