Cleared Traditional

Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile (K190606) - FDA 510(k) Clearance

Class I General Hospital device.

K190606 · Kossan International Sdn Bhd · General Hospital
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May 2019
Decision
81d
Days
Class 1
Risk

K190606 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Kossan International Sdn Bhd (Klang, MY). The FDA issued a Cleared decision on May 28, 2019 after a review of 81 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 Kossan International Sdn Bhd devices

Submission Details

510(k) Number K190606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2019
Decision Date May 28, 2019
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
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 K190606.
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K182851 · O&M Halyard, Inc. · Jun 2019
Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
K183354 · Gx Corporation Sdn Bhd · Jun 2019
Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
K182308 · Sri Trang Gloves (Thailand) Co., Ltd. · May 2019
Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
K182612 · Zibo Yahao Supplies Co., Ltd. · May 2019
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)
K182640 · Shandong Hengya Packaging Printing Co.,Ltd · Apr 2019
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K183287 · Kossan International Sdn Bhd · Apr 2019