Cleared Traditional

Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim (K183149) - FDA 510(k) Clearance

Class I General Hospital device.

K183149 · Central Medicare Sdn Bhd · General Hospital
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Jul 2019
Decision
233d
Days
Class 1
Risk

K183149 is an FDA 510(k) clearance for the Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with .... Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Central Medicare Sdn Bhd (Teluk Intan, MY). The FDA issued a Cleared decision on July 4, 2019 after a review of 233 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 Central Medicare Sdn Bhd devices

Submission Details

510(k) Number K183149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2018
Decision Date July 04, 2019
Days to Decision 233 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
104d slower than avg
Panel avg: 129d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 - LZC Medical Glove, Specialty

All 28
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K183149.
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
K191230 · O&M Halyard, Inc. · Nov 2019
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
K183562 · Encompass Industries Sdn. Bhd. · Oct 2019
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
K182382 · Gmp Medicare Sdn Bhd (F25) · Aug 2019
Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
K190159 · Showa Best Glove, Inc. · May 2019
Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue
K182383 · Yty Industry (Manjung) Sdn Bhd · Mar 2019
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K183132 · O&M Halyard, Inc. · Feb 2019