Cleared Traditional

K140050 - NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE

K140050 is an FDA 510(k) clearance for NITRILE POWDER FREE EXAMINATION GLOVE W..., manufactured by Hartalega Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K140050 · Hartalega Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
246d
Days
Class 1
Risk

K140050 is an FDA 510(k) clearance for the NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECT.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Bestari Jaya, MY). The FDA issued a Cleared decision on September 12, 2014 after a review of 246 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.

FDA 510(k) Submission Details - K140050

510(k) Number K140050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2014
Decision Date September 12, 2014
Days to Decision 246 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 129d · This submission: 246d
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 1180
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K140050.
EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
K141579 · Eco Medi Glove Sdn. Bhd. · Oct 2014
EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K141510 · Eco Medi Glove Sdn. Bhd. · Oct 2014
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
K141623 · Eco Medi Glove Sdn. Bhd. · Oct 2014
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K140418 · Wrp Rubber Products Sdn Bhd · Sep 2014
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
K141590 · Eco Medi Glove Sdn. Bhd. · Sep 2014
POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
K141021 · Hl Rubber Industries Sdn Bhd · Aug 2014
K140050 · NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
Download PDF Hartalega Sdn Bhd