Cleared Traditional

K140418 - POWDER FREE BLUE NITRILE PATIENT EXAMIN...

K140418 is an FDA 510(k) clearance for POWDER FREE BLUE NITRILE PATIENT EXAMIN..., manufactured by Wrp Rubber Products Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K140418 · Wrp Rubber Products Sdn Bhd · General Hospital
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Sep 2014
Decision
197d
Days
Class 1
Risk

K140418 is an FDA 510(k) clearance for the POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wrp Rubber Products Sdn Bhd (Sepang ,Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on September 3, 2014 after a review of 197 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 Wrp Rubber Products Sdn Bhd devices

FDA 510(k) Submission Details - K140418

510(k) Number K140418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date September 03, 2014
Days to Decision 197 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 129d · This submission: 197d
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 750
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K140418.
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
K142283 · Yty Industry (Manjung) Sdn Bhd · Jan 2015
Nitrile Powder Free Examination Glove (Blue)
K142588 · Hartalega Sdn Bhd · Dec 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
K140050 · Hartalega Sdn Bhd · Sep 2014
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K133168 · Wrp Asia Pacific Sdn. Bhd. · Aug 2014
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)
K140890 · Hartalega NGC Sdn. Bhd. · Jul 2014
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
K133689 · Pt. Medisafe Technologies · Jul 2014