Cleared Traditional

K141590 - EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE

K141590 is an FDA 510(k) clearance for EMG BLUE NITRILE MEDICAL EXAMINATION GL..., manufactured by Eco Medi Glove Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K141590 · Eco Medi Glove Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
82d
Days
Class 1
Risk

K141590 is an FDA 510(k) clearance for the EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Eco Medi Glove Sdn. Bhd. (Kamunting Perak, MY). The FDA issued a Cleared decision on September 3, 2014 after a review of 82 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 Eco Medi Glove Sdn. Bhd. devices

FDA 510(k) Submission Details - K141590

510(k) Number K141590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2014
Decision Date September 03, 2014
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
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 1150
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K141590.
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
K141623 · Eco Medi Glove Sdn. Bhd. · Oct 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
K140050 · Hartalega Sdn Bhd · Sep 2014
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K140418 · Wrp Rubber Products Sdn Bhd · Sep 2014
POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
K141021 · Hl Rubber Industries Sdn Bhd · Aug 2014
BLUE NITRILE POWDER FREE EXAM GLOVES
K133325 · Shandong Xinshi Medical Products Co., Ltd. · Aug 2014
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K133168 · Wrp Asia Pacific Sdn. Bhd. · Aug 2014