Cleared Traditional

Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K200181) - FDA 510(k) Clearance

Class I General Hospital device.

K200181 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
82d
Days
Class 1
Risk

K200181 is an FDA 510(k) clearance for the Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chem.... 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 April 15, 2020 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Comfort Rubber Gloves Industries Sdn. Bhd. devices

Submission Details

510(k) Number K200181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2020
Decision Date April 15, 2020
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
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 K200181.
Latex Examination Powder Free Glove, Aloe Vera
K193150 · Top Glove Sdn. Bhd. · Jun 2020
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC
K200453 · Yty Industry (Manjung) Sdn Bhd · May 2020
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
K200581 · Hartalega NGC Sdn. Bhd. · Apr 2020
KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
K200072 · Kimberly Clark Corporation · Apr 2020
Powder Free Nitrile Examination Glove (Aqua Green)
K200326 · Riverstone Resources Sdn Bhd · Apr 2020
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
K200539 · Sri Trang Gloves (Thailand) Public Company Limited · Apr 2020