Cleared Traditional

K152937 - EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented

K152937 is an FDA 510(k) clearance for EMG Powder Free Nitrile Examination Glo..., 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 262-day FDA review.

K152937 · Eco Medi Glove Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
262d
Days
Class 1
Risk

K152937 is an FDA 510(k) clearance for the EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented. 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 June 23, 2016 after a review of 262 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 Eco Medi Glove Sdn. Bhd. devices

FDA 510(k) Submission Details - K152937

510(k) Number K152937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2015
Decision Date June 23, 2016
Days to Decision 262 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
133d slower than avg
Panel avg: 129d · This submission: 262d
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 1149
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K152937.
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
K151824 · Kossan International Sdn Bhd · Aug 2016
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
K160467 · Kossan International Sdn Bhd · Aug 2016
Powder Free Blue Nitrile Examination Glove
K153732 · Qube Medical Product Sdn Bhd · Jul 2016
Nitrile Patient Examination gloves, Powderfree, Blue color
K143477 · Primus Gloves Pvt Limited · Apr 2016
HG Pro Nitrile Powder Free Examination Gloves
K152479 · Healthy Glove Co., Ltd. · Apr 2016
Powder Free Blue Nitrile Examination Glove
K153562 · Vietglove Corporation · Apr 2016