Cleared Traditional

Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims (K181066) - FDA 510(k) Clearance

Class I General Hospital device.

K181066 · Eco Medi Glove Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
156d
Days
Class 1
Risk

K181066 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and wi.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Eco Medi Glove Sdn. Bhd. (Perak, MY). The FDA issued a Cleared decision on September 26, 2018 after a review of 156 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

Submission Details

510(k) Number K181066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2018
Decision Date September 26, 2018
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K181066.
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
K182096 · Owens & Minor Halyard, Inc. · Nov 2018
SBG Blue Nitrile Powder Free Medical Examination Glove
K180467 · Showa Best Glove, Inc. · Oct 2018
SBG Black Nitrile Powder Free Medical Examination Glove
K180468 · Showa Best Glove, Inc. · Oct 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
K173509 · Hartalega Sdn Bhd · Aug 2018
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
K180644 · Hartalega Sdn Bhd · Aug 2018
Nitrile Patient Examination Powder Free Glove, Textured, Black
K161085 · Multisafe Sdn. Bhd. · Jul 2018