Cleared Traditional

Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl (K192954) - FDA 510(k) Clearance

Class I General Hospital device.

K192954 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
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Jun 2020
Decision
242d
Days
Class 1
Risk

K192954 is an FDA 510(k) clearance for the Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on June 19, 2020 after a review of 242 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 Comfort Rubber Gloves Industries Sdn. Bhd. devices

Submission Details

510(k) Number K192954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2019
Decision Date June 19, 2020
Days to Decision 242 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
113d slower than avg
Panel avg: 129d · This submission: 242d
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 K192954.
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
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Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
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K193150 · Top Glove Sdn. Bhd. · Jun 2020