Cleared Traditional

Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim (K191800) - FDA 510(k) Clearance

Class I General Hospital device.

K191800 · Kossan International Sdn Bhd · General Hospital
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Sep 2019
Decision
75d
Days
Class 1
Risk

K191800 is an FDA 510(k) clearance for the Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogen.... 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 September 16, 2019 after a review of 75 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 K191800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2019
Decision Date September 16, 2019
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
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 K191800.
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
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K190454 · Hartalega NGC Sdn. Bhd. · Sep 2019
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Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
K190403 · Ever Global (Vietnam) Enterprise Corporation · Sep 2019
Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
K182089 · Platinum Glove Industries Sdn. Bhd. · Jul 2019
PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs
K183280 · Smart Glove Corporation Sdn. Bhd. · Jul 2019