Cleared Traditional

Nitrile Powder Free Examination Gloves Biodegradable (Green) (K240269) - FDA 510(k) Clearance

Class I General Hospital device.

K240269 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
268d
Days
Class 1
Risk

K240269 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Gloves Biodegradable (Green). 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 October 25, 2024 after a review of 268 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 K240269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2024
Decision Date October 25, 2024
Days to Decision 268 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
139d slower than avg
Panel avg: 129d · This submission: 268d
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 K240269.
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K241909 · O&M Halyard, Inc. · Sep 2024
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
K241745 · Ksg Medicare Sdn. Bhd. · Sep 2024