Cleared Traditional

K113440 - HIGH FIVE

K113440 is an FDA 510(k) clearance for HIGH FIVE, manufactured by Central Medicare Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K113440 · Central Medicare Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
184d
Days
Class 1
Risk

K113440 is an FDA 510(k) clearance for the HIGH FIVE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Central Medicare Sdn Bhd (Diamond Bar, US). The FDA issued a Cleared decision on May 23, 2012 after a review of 184 days - an extended review 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: 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.

View all Central Medicare Sdn Bhd devices

FDA 510(k) Submission Details - K113440

510(k) Number K113440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date May 23, 2012
Days to Decision 184 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
55d slower than avg
Panel avg: 129d · This submission: 184d
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 1145
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K113440.
BLUE POWER FREE NITRILE EXAMINATION GLOVE
K121464 · Northstar Healthcare Holdings · Jul 2012
UTB BLUE POWDER FREE NITRILE
K121506 · Northstar Healthcare Holdings · Jul 2012
LANO-E
K111718 · Ug Global Resources Sdn. Bhd. · Jun 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
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED
K120184 · Encompass Medical Supplies Inc Limited · May 2012